Derma-Smoothe/FS

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of the labeling: • Endocrine System Adverse Reactions [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] • Local Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Ophthalmic Adverse Reactions [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (≥ 5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%). ( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Hill Dermaceuticals, Inc. at 1-800-344-5707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. An open-label trial was conducted in 58 pediatric subjects 2 years to 12 years of age with moderate to severe atopic dermatitis to evaluate the safety of DERMA-SMOOTHE/FS Body Oil when applied to the face twice daily for 4 weeks. Adverse reactions reported by ≥2% of pediatric subjects treated with DERMA-SMOOTHE/FS Body Oil are shown in Table 1. Table 1: Adverse Reactions in ≥2% of Pediatric Subjects 2 Years to 12 Years of Age with Moderate to Severe Atopic Dermatitis, Treated with DERMA-SMOOTHE/FS Body Oil, N=58 Adverse Reaction (AR) The number of individual adverse reactions reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reports of an adverse reaction. n (%) Day 14 Day 28 End of Treatment Day 56 Four Weeks Post Treatment Any AE 15 (26) 6 (10) 7 (12) 7 (12) Telangiectasia 5 (9) 3 (5) 4 (7) 2 (4) Erythema 3 (5) 3 (5) Itching 3 (5) 3 (5) Irritation 3 (5) 3 (5) Burning 3 (5) 3 (5) Hypopigmentation 2 (4) 2 (4) Shiny skin 1 (2) 1 (2) Secondary atopic dermatitis 1 (2) 1 (2) Papules and pustules 1 (2) 1 (2) Keratosis pilaris 1 (2) 1 (2) Folliculitis 1 (2) 1 (2) Facial herpes simplex 1 (2) 1 (2) Acneiform eruption 1 (2) 1 (2) Ear infection 1 (2) 1 (2) An open-label safety trial was conducted in 29 pediatric subjects 3 months to 2 years of age to assess the HPA axis by ACTH stimulation testing following use of DERMA-SMOOTHE/FS Body Oil twice daily for 4 weeks. The trial included 7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years. All subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area (BSA). Eleven (11) subjects had baseline BSA involvement of 50% to 75% and 7 subjects had BSA involvement of greater than 75% [see Use in Specific Populations (8.4) ] . The most common adverse reactions reported in the study (≥2%) are shown in Table 2. Table 2: Adverse Reactions in ≥2% of Pediatric Subjects 3 Months to 2 Years of Age with Moderate to Severe Atopic Dermatitis, Treated with DERMA-SMOOTHE/FS Body Oil, N=30 Includes one subject who withdrew at Week 2 Adverse Reaction n (%) Cough 6 (20) Rhinorrhea 4 (13) Pyrexia 3 (10) Nasopharyngitis 2 (7) Hypopigmentation 2 (7) Abscess 1 (3) Atopic Dermatitis 1 (3) Eczema 1 (3) Hyperpigmentation 1 (3) Molluscum 1 (3) Rash 1 (3) Diarrhea 1 (3) Otitis Media 1 (3) URI 1 (3) Vomiting 1 (3) 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of products containing topical corticosteroids. Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Endocrine Disorders: HPA axis suppression and Cushing’s syndrome [see Use in Specific Populations (8.4) ] • Eye Disorders: glaucoma and cataracts [see Warnings and Precautions (5.3) ] • Nervous System Disorders: intracranial hypertension including bulging fontanelles, headaches, and bilateral papilledema [see Use in Specific Populations (8.4) ]

4 CONTRAINDICATIONS None. None. ( 4 )

11 DESCRIPTION DERMA-SMOOTHE/FS Body Oil (fluocinolone acetonide), topical oil, 0.01% contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17 [(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of DERMA-SMOOTHE/FS Body Oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil and fragrances. DERMA-SMOOTHE/FS Body Oil is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in DERMA-SMOOTHE/FS Body Oil is heated at 246°C (475°F) for at least 15 minutes. The refined peanut oil used in DERMA-SMOOTHE/FS Body Oil is routinely tested for peanut proteins through amino acid analysis; the quantity of amino acids is below 0.5 parts per million (ppm). Chemical Structure

2 DOSAGE AND ADMINISTRATION • DERMA-SMOOTHE/FS Body Oil is not for oral, ophthalmic, or intravaginal use. ( 2.1 ) • Do not use on face or intertriginous areas. ( 2.1 ) • Adult patients: Apply to affected areas 3 times daily. ( 2.2 ) • Pediatric patients: Moisten skin and apply to affected areas twice daily for up to 4 weeks. ( 2.3 ) 2.1 Important Administration Instructions DERMA-SMOOTHE/FS Body Oil is for topical use only. Not for oral, ophthalmic, or intravaginal use. Apply the least amount of DERMA-SMOOTHE/FS Body Oil needed to cover the affected areas. Discontinue use when control of disease is achieved within 2 weeks or contact the healthcare provider if no improvement is seen within 2 weeks. Do not use on the face, axillae, or groin unless directed by the healthcare provider. Do not apply to intertriginous areas due to the increased risk of local adverse reactions [see Adverse Reactions (6) and Use in Specific Populations (8.4) ] . Do not apply to the diaper area; diapers or plastic pants may constitute occlusive use [see Warnings and Precautions (5.1)] . 2.2 Recommended Dosage in Adults Apply DERMA-SMOOTHE/FS Body Oil as a thin film to the affected areas three times daily. 2.3 Recommended Dosage in Pediatric Patients Moisten skin and apply DERMA-SMOOTHE/FS Body Oil as a thin film to the affected areas twice daily for up to four weeks.

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in atopic dermatitis is unknown. 12.2 Pharmacodynamics Vasoconstrictor Assay DERMA-SMOOTHE/FS Body Oil is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression HPA axis suppression was evaluated in 29 pediatric subjects 3 months to 2 years old (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years) and 33 pediatric subjects 2 years to 12 years old (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe atopic dermatitis. Subjects were treated with DERMA-SMOOTHE/FS Body Oil twice daily for 4 weeks. Morning pre-stimulation and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. In subjects 3 months to 2 years old, all subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 µg/dL). In subjects 2 to 12 years old, 4 out of 18 subjects 2 to 5 years old showed low pre-stimulation cortisol levels (3.2 to 6.6 µg/dL; normal: cortisol > 7µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL) at the end of treatment [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] . 12.3 Pharmacokinetics Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may increase percutaneous absorption. The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

12.1 Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in atopic dermatitis is unknown.

12.2 Pharmacodynamics Vasoconstrictor Assay DERMA-SMOOTHE/FS Body Oil is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression HPA axis suppression was evaluated in 29 pediatric subjects 3 months to 2 years old (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years) and 33 pediatric subjects 2 years to 12 years old (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe atopic dermatitis. Subjects were treated with DERMA-SMOOTHE/FS Body Oil twice daily for 4 weeks. Morning pre-stimulation and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. In subjects 3 months to 2 years old, all subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 µg/dL). In subjects 2 to 12 years old, 4 out of 18 subjects 2 to 5 years old showed low pre-stimulation cortisol levels (3.2 to 6.6 µg/dL; normal: cortisol > 7µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL) at the end of treatment [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] .

12.3 Pharmacokinetics Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may increase percutaneous absorption. The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

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3 DOSAGE FORMS AND STRENGTHS DERMA-SMOOTHE/FS Body Oil is a topical oil containing 0.01% fluocinolone acetonide, supplied in bottles containing 4 fluid ounces. DERMA-SMOOTHE/FS Body Oil is a topical oil containing 0.01% fluocinolone acetonide supplied in bottles containing 4 fluid ounces. ( 3 )

Derma-Smoothe/FS fluocinolone acetonide fluocinolone acetonide fluocinolone acetonide ISOPROPYL ALCOHOL ISOPROPYL MYRISTATE LIGHT MINERAL OIL OLETH-2 PEANUT OIL

13.1 Carcinogenesis, mutagenesis, impairment of fertility No carcinogenicity, genotoxicity, or fertility studies were conducted with DERMA-SMOOTHE/FS Body Oil. However, some corticosteroids are genotoxic in various genotoxicity tests (i.e., the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation, the in vivo mouse bone marrow micro nucleus assay, the Chinese hamster micronucleus test, and the in vitro mouse lymphoma gene mutation assay).

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, mutagenesis, impairment of fertility No carcinogenicity, genotoxicity, or fertility studies were conducted with DERMA-SMOOTHE/FS Body Oil. However, some corticosteroids are genotoxic in various genotoxicity tests (i.e., the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation, the in vivo mouse bone marrow micro nucleus assay, the Chinese hamster micronucleus test, and the in vitro mouse lymphoma gene mutation assay).

NDA019452

Derma-Smoothe/FS

fluocinolone acetonide

68791-101

HUMAN PRESCRIPTION DRUG

TOPICAL

Principal Display Panel PRINCIPAL DISPLAY PANEL - 118.28 mL Carton Label NDC 68791-101-04 Rx only Derma-Smoothe/FS ® Fluocinolone Acetonide 0.01% Topical Oil (BODY OIL) FOR TOPICAL USE ONLY NOT FOR ORAL, OPHTHALMIC, or INTRAVAGINAL USE SHAKE WELL BEFORE USE Net Contents 118.28 mL (4 fL. oz.) ROYAL PHARMACEUTICALS ® PRINCIPAL DISPLAY PANEL - 20 mL Carton Physcian Sample Label NOT FOR SALE PHYSICIAN SAMPLE NDC 68791-101-01 Rx only Derma-Smoothe/FS® Fluocinolone Acetonide 0.01% Topical Oil (BODY OIL) FOR TOPICAL USE ONLY NOT FOR ORAL OPHTHALMIC, OR INTRAVAGINAL USE SHAKE WELL BEFORE USE NET Contents: 20 mL Royal Pharmaceuticals® 118.28 mL Carton Label 20 mL Carton Label

Manufactured by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 For: Royal Pharmaceutical, Inc. Wall, NJ 07719 DERMA-SMOOTHE/FS is a registered trademark of Hill Dermaceuticals, Inc. © 2024 Hill Dermaceuticals, Inc. All rights reserved.

17 PATIENT COUNSELING INFORMATION Administration Instructions Advise patients that DERMA-SMOOTHE/FS Body Oil is for topical use only [see Dosage and Administration (2.1) ] . Advise patients to not to apply DERMA-SMOOTHE/FS Body Oil under occlusion unless directed by their healthcare provider. Instruct patients not to apply DERMA-SMOOTHE/FS to the diaper area as diapers or plastic pants may constitute occlusive use [see Dosage and Administration (2.1) ] . Advise patients to avoid use of DERMA-SMOOTHE/FS Body Oil on the face, axillae, or groin unless directed by their healthcare provider [see Dosage and Administration (2.1) ] . Advise patients to discontinue therapy when control of disease is achieved. Instruct patients to contact their healthcare provider if no improvement is seen within 2 weeks [see Dosage and Administration (2.1) ] . Endocrine System Adverse Reactions Instruct patients not to use other corticosteroid-containing products while using DERMA-SMOOTHE/FS Body Oil without first consulting their healthcare provider [see Warnings and Precautions (5.1) ] . Ophthalmic Adverse Reactions Advise patients to avoid contact with the eyes and in case of contact, wash eyes liberally with water. Instruct patients to tell their healthcare provider if they develop any visual symptoms [see Warnings and Precautions (5.3) ]. Pregnancy and Lactation Advise patients to use DERMA-SMOOTHE/FS Body Oil on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise patients that are breastfeeding not to apply DERMA-SMOOTHE/FS Body Oil directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.1 and 8.2) ] .

8.4 Pediatric Use The safety and effectiveness of DERMA-SMOOTHE/FS Body Oil for the topical treatment of moderate to severe atopic dermatitis have been established in pediatric patients aged 3 months and older for up to 4 weeks. Safety and effectiveness of DERMA-SMOOTHE/FS Body Oil in pediatric patients with atopic dermatitis below the age of 3 months have not been established. Systemic Adverse Reactions in Pediatric Patients HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids [see Warnings and Precautions (5.1) ] . Evaluation in Peanut-Sensitive Pediatric Patients A clinical trial was conducted to assess the safety of DERMA-SMOOTHE/FS Body Oil, which contains refined peanut oil, on pediatric subjects with known peanut allergies. The study enrolled 13 pediatric subjects with atopic dermatitis, 6 to 17 years of age. Of the 13 subjects, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The trial evaluated the subjects' responses to both prick test and patch test utilizing refined peanut oil, DERMA-SMOOTHE/FS Body Oil and histamine/saline controls. Subjects were also treated with DERMA-SMOOTHE/FS Body Oil twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to DERMA-SMOOTHE/FS Body Oil and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of DERMA-SMOOTHE/FS Body Oil. Evaluation in Pediatric Patients 2 to 6 years old Use of DERMA-SMOOTHE/FS Body Oil in pediatric patients 2 to 6 years old is supported by open-label safety trials conducted in 33 pediatric subjects (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. Subjects were treated with DERMA-SMOOTHE/FS Body Oil twice daily for 4 weeks. Morning pre-stimulation cortisol and post-ACTH stimulation cortisol levels were obtained in each subject the beginning of the trial and at the end of 4 weeks of treatment. At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 µg/dL; normal: cortisol > 7µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL) [see Clinical Pharmacology (12.2) ] . Evaluation in Pediatric Patients 3 months to 2 years old Use of DERMA-SMOOTHE/FS Body Oil in pediatric patients 3 months to 2 years old is supported by an open-label safety trial conducted in 29 pediatric subjects (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years) to assess the HPA axis by ACTH stimulation testing following use of DERMA-SMOOTHE/FS Body Oil twice daily for 4 weeks [see Adverse Reactions (6.1) ] . Morning pre-stimulation and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. All subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 µg/dL) [see Clinical Pharmacology (12.2) ] .

8.1 Pregnancy Risk Summary Available data from case reports, case series, and observational studies on fluocinolone acetonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Observational studies suggest maternal use of high to super-high potency topical steroids may be associated with an increased risk of low birthweight infants. Advise pregnant women to use DERMA-SMOOTHE/FS Body Oil on the smallest area of skin and for the shortest duration possible. Corticosteroids can cause fetal malformations in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids cause fetal malformations after dermal application in laboratory animals. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Available data from case reports, case series, and observational studies on fluocinolone acetonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Observational studies suggest maternal use of high to super-high potency topical steroids may be associated with an increased risk of low birthweight infants. Advise pregnant women to use DERMA-SMOOTHE/FS Body Oil on the smallest area of skin and for the shortest duration possible. Corticosteroids can cause fetal malformations in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids cause fetal malformations after dermal application in laboratory animals. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. 8.2 Lactation Risk Summary There is no information regarding the presence of fluocinolone acetonide in breast milk or its effects on the breastfed infant or on milk production. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. To minimize potential exposure to the breastfed infant via breast milk, use DERMA-SMOOTHE/FS Body Oil on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply DERMA-SMOOTHE/FS Body Oil directly to the nipple and areola to avoid direct infant exposure [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DERMA-SMOOTHE/FS Body Oil and any potential adverse effects on the breastfed infant from DERMA-SMOOTHE/FS Body Oil or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of DERMA-SMOOTHE/FS Body Oil for the topical treatment of moderate to severe atopic dermatitis have been established in pediatric patients aged 3 months and older for up to 4 weeks. Safety and effectiveness of DERMA-SMOOTHE/FS Body Oil in pediatric patients with atopic dermatitis below the age of 3 months have not been established. Systemic Adverse Reactions in Pediatric Patients HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids [see Warnings and Precautions (5.1) ] . Evaluation in Peanut-Sensitive Pediatric Patients A clinical trial was conducted to assess the safety of DERMA-SMOOTHE/FS Body Oil, which contains refined peanut oil, on pediatric subjects with known peanut allergies. The study enrolled 13 pediatric subjects with atopic dermatitis, 6 to 17 years of age. Of the 13 subjects, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The trial evaluated the subjects' responses to both prick test and patch test utilizing refined peanut oil, DERMA-SMOOTHE/FS Body Oil and histamine/saline controls. Subjects were also treated with DERMA-SMOOTHE/FS Body Oil twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to DERMA-SMOOTHE/FS Body Oil and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of DERMA-SMOOTHE/FS Body Oil. Evaluation in Pediatric Patients 2 to 6 years old Use of DERMA-SMOOTHE/FS Body Oil in pediatric patients 2 to 6 years old is supported by open-label safety trials conducted in 33 pediatric subjects (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. Subjects were treated with DERMA-SMOOTHE/FS Body Oil twice daily for 4 weeks. Morning pre-stimulation cortisol and post-ACTH stimulation cortisol levels were obtained in each subject the beginning of the trial and at the end of 4 weeks of treatment. At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 µg/dL; normal: cortisol > 7µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL) [see Clinical Pharmacology (12.2) ] . Evaluation in Pediatric Patients 3 months to 2 years old Use of DERMA-SMOOTHE/FS Body Oil in pediatric patients 3 months to 2 years old is supported by an open-label safety trial conducted in 29 pediatric subjects (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years) to assess the HPA axis by ACTH stimulation testing following use of DERMA-SMOOTHE/FS Body Oil twice daily for 4 weeks [see Adverse Reactions (6.1) ] . Morning pre-stimulation and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. All subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 µg/dL) [see Clinical Pharmacology (12.2) ] .

16 HOW SUPPLIED / STORAGE AND HANDLING DERMA-SMOOTHE/FS Body Oil (fluocinolone acetonide) topical oil, 0.01% (NDC # 68791-101-04) is supplied in bottles containing 4 fluid ounces. Storage: Keep tightly closed. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Storage: Keep tightly closed. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].