1 INDICATIONS AND USAGE Clobetasol Propionate Lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older.

( 1.1 ).

Limitations of Use: Do not use on the face, axillae or groin.

( 1.2 ) Do not use if atrophy is present at the treatment site.

( 1.2 ) Do not use for rosacea or perioral dermatitis.

( 1.2 ) 1.1 Indication Clobetasol Propionate Lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older.

Treatment should be limited to 2 consecutive weeks.

For moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment.

Any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression before prescribing for more than 2 weeks.

The total dosage should not exceed 50 g (50 mL or 1.75 fl.

oz) per week.

Patients should be instructed to use Clobetasol Propionate Lotion, 0.05% for the minimum amount of time necessary to achieve the desired results [see Dosage and Administration (2) ].

Use in patients under 18 years of age is not recommended due to numerically high rates of HPA axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ].

1.2 Limitations of Use Clobetasol Propionate Lotion, 0.05% should not be used on the face, axillae, or groin and should not be used if there is atrophy at the treatment site.

Clobetasol Propionate Lotion, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.

6 ADVERSE REACTIONS The most common adverse reactions (incidence greater than 1%) are skin atrophy, telangiectasia, discomfort skin and skin dry.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials 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.

In controlled, clinical trials with Clobetasol Propionate Lotion, 0.05%, the following adverse reactions have been reported: burning/stinging, skin dryness, irritation, erythema, folliculitis, pruritus, skin atrophy, and telangiectasia.

The pooled incidence of local adverse reactions in trials for psoriasis and atopic dermatitis with Clobetasol Propionate Lotion, 0.05% at 1% or greater was: Table 1: Adverse Reactions with Incidence ≥1% in Clinical Trials Adverse Reaction Incidence Skin Atrophy 4.2% Telangiectasia 3.2% Discomfort Skin 1.3% Skin Dry 1.0% Most local adverse events were rated as mild to moderate and they are not affected by age, race or gender.

Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

6.2 Postmarketing Experience 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 Propionate Lotion, 0.05%.

Endocrine disorders: Cushing’s syndrome, Adrenal suppression Skin: Rash, Pain of skin, Skin exfoliation, Skin chapped, Scaling, Induration/papulation, Lichenification.

Other: Psoriasis (aggravation), Plaque elevation, Excoriation.