-smoothe/fs ® needed to cover the affected areas. as with other corticosteroids, derma-smoothe/fs ® should be discontinued when control of disease is achieved. contact the physician if no improvement is seen within 2 weeks. derma-smoothe/fs ® should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. derma-smoothe/fs ® should not be used on the face, axillae, or groin unless directed by the physician. application to intertriginous areas should be avoided due to the increased risk of local adverse reactions. [see adverse reactions (6) and use in specific populations (8.4) ] .

syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticosteroids. because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for hpa axis suppression. the acth stimulation test may be helpful in evaluating patients for hpa axis suppression. if hpa axis suppression is documented, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. recovery of hpa axis function is generally prompt upon discontinuation of topical corticosteroids. conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, and use of occlusive dressings. manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. [see use in specific populations (8.4) ] 5.2 local adverse reactions with topical corticosteroids local adverse reactions may occur with use of topical corticosteroids and may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. some local adverse reactions may be irreversible. reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. [see adverse reactions (6.1) ] 5.3 allergic contact dermatitis with topical corticosteroids allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing. 5.4 concomitant skin infections concomitant skin infections should be treated with an appropriate antimicrobial agent. if the infection persists unchanged, derma-smoothe/fs ® should be discontinued until the infection has been adequately treated. 5.5 use in peanut-sensitive individuals physicians should use caution in prescribing derma-smoothe/fs ® for peanut-sensitive individuals. [see description (11) ] should signs of hypersensitivity present (wheal and flare reactions, pruritus, or other manifestations), or should disease exacerbations occur, derma-smoothe/fs ® should be discontinued immediately and appropriate therapy instituted.

er of individual adverse reactions reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse reaction. # of subjects (%) 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) 6.2 clinical studies experience: evaluation in pediatric subjects 3 months to 2 years old an open-label safety study was conducted in 29 children to assess the hpa axis by acth stimulation testing following use of derma-smoothe/fs ® twice daily for 4 weeks. the following adverse reactions were reported in the study [see use in specific populations (8.4) ]; adverse reactions (%), n=30 includes one subject who withdrew at week 2 adverse reaction # of subjects (%) diarrhea 1 (3) vomiting 1 (3) pyrexia 3 (10) abscess 1 (3) molluscum 1 (3) nasopharyngitis 2 (7) uri 1 (3) otitis media 1 (3) cough 6 (20) rhinorrhea 4 (13) atopic dermatitis 1 (3) eczema 1 (3) hyperpigmentation 1 (3) hypopigmentation 2 (7) rash 1 (3)

derma-smoothe/fs ® is administered to a nursing woman. 8.4 pediatric use 8.4.1 systemic adverse reactions in pediatric patients hpa axis suppression, cushing's syndrome, and intracranial hypertension have been reported in children 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, children are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids. [see warnings and precautions (5.1) ] 8.4.2 evaluation in peanut-sensitive pediatric subjects a clinical study was conducted to assess the safety of derma-smoothe/fs ® , which contains refined peanut oil, on subjects with known peanut allergies. the study enrolled 13 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 study evaluated the subjects' responses to both prick test and patch test utilizing peanut oil nf, derma-smoothe/fs ® and histamine/saline controls. subjects were also treated with derma-smoothe/fs ® twice daily for 7 days. prick test and patch test results for all 13 patients were negative to derma-smoothe/fs ® 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 ® . the bulk peanut oil nf, used in derma-smoothe/fs ® is heated at 475°f for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins. [see description (11) ] 8.4.3 evaluation in pediatric subjects 2 to 6 years old open-label safety studies were conducted on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. subjects were treated with derma-smoothe/fs ® twice daily for 4 weeks. baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. morning pre-stimulation cortisol 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. 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). 8.4.4 evaluation in pediatric subjects 3 months to 2 years old an open-label safety study was conducted in 29 children (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months and 15 subjects ages > 12 months to 2 years of age) to assess the hpa axis by acth stimulation testing following use of derma-smoothe/fs ® twice daily for 4 weeks. all subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area. baseline body surface area involvement was 50% to 75% in 11 subjects and greater than 75% in 7 subjects. 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).

of age. of the 13 subjects, 9 were radioallergosorbent test (rast) positive to peanuts and 4 had no peanut sensitivity (controls). the study evaluated the subjects' responses to both prick test and patch test utilizing peanut oil nf, derma-smoothe/fs ® and histamine/saline controls. subjects were also treated with derma-smoothe/fs ® twice daily for 7 days. prick test and patch test results for all 13 patients were negative to derma-smoothe/fs ® 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 ® . the bulk peanut oil nf, used in derma-smoothe/fs ® is heated at 475°f for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins. [see description (11) ] 8.4.3 evaluation in pediatric subjects 2 to 6 years old open-label safety studies were conducted on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. subjects were treated with derma-smoothe/fs ® twice daily for 4 weeks. baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. morning pre-stimulation cortisol 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. 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). 8.4.4 evaluation in pediatric subjects 3 months to 2 years old an open-label safety study was conducted in 29 children (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months and 15 subjects ages > 12 months to 2 years of age) to assess the hpa axis by acth stimulation testing following use of derma-smoothe/fs ® twice daily for 4 weeks. all subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area. baseline body surface area involvement was 50% to 75% in 11 subjects and greater than 75% in 7 subjects. 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).

ase 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. derma-smoothe/fs ® is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies.

first consulting your physician.