You may report side effects to FDA at 1-800-FDA-1088.Keep clobetasol propionate emulsion foam and all medicines out of the reach of childrenMedicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Wash your hands before and after use. Such an observation should be corroborated with appropriate diagnostic patch testing.Clobetasol propionate foam is flammable. Most local adverse events were rated as mild to moderate and they were not affected by age, race, or gender.Because these 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.The following adverse reactions have been identified during post-approval use of clobetasol formulations: erythema, pruritus, burning, alopecia, and dryness.The following additional local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. 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.Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. It is available as a generic and under the brand names Temovate, Clobex and Cormax. Topical corticosteroids may have other endocrine effects. The majority of exposed subjects treated large areas of the body (a mean quantity of 60 g/month [range, 12 to 170 g]) over long periods of time.Embryofetal development studies conducted with clobetasol propionate in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and malformations at all dose levels tested down to 0.03 mg/kg. Advise breastfeeding women not to apply Clobetasol propionate foam directly to the nipple and areola to avoid direct infant exposure Clobetasol propionate foam is a prescription corticosteroid medicine used in people 12 years of age and older for the treatment of:It is not known if Clobetasol propionate foam is safe and effective in children under 12 years of age.Clobetasol propionate foam is not recommended in children under 12 years of age.Tell your healthcare provider about all the medicine you take including prescription or over‑the-counter medicines, vitamins, and herbal supplements. Patients should inform their physician(s) that they are using Clobetasol propionate foam if surgery is contemplated Advise patients to report any visual symptoms to their healthcare providers Report any signs of local adverse reactions to the physician. [See USP Controlled Room Temperature.]FLAMMABLE. Patients should inform their physician(s) that they are using clobetasol propionate emulsion foam if surgery is contemplated Advise patients to report any visual symptoms to their healthcare providers Report any signs of local adverse reactions to the physician. Do not expose to heat or store at temperatures above 120°F (49°C).Clobetasol propionate emulsion foam may cause HPA axis suppression. Clobetasol propionate emulsion foam is a corticosteroid indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged 12 years and older. Subjects were treated twice daily for 2 weeks with one of 4 treatments: Clobetasol propionate foam, vehicle foam, a commercially available clobetasol propionate solution (TEMOVATE Subjects with parameter Clear at endpoint (scalp psoriasis)Another well-controlled clinical trial evaluated 279 subjects with mild to moderate plaque-type psoriasis (mean body surface area at baseline was 6.7% with a range from 1% to 20%) of non‑scalp regions. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment.HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This may occur during treatment or upon withdrawal of the topical corticosteroid. They are, therefore, also at greater risk of adrenal insufficiency upon the use of topical corticosteroids.Rare systemic toxicities such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients especially those with prolonged exposure to large doses of high potency topical corticosteroids.Local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients.Avoid use of Clobetasol propionate foam in the treatment of diaper dermatitis.Clinical studies of Clobetasol propionate foam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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