Adapalene
Adapalene is an FDA drug label for the active ingredient ADAPALENE manufactured by Padagis Israel Pharmaceuticals Ltd administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230725.
Generic: ADAPALENE
Manufacturer: Padagis Israel Pharmaceuticals Ltd
Product Type: HUMAN PRESCRIPTION DRUG
Route: TOPICAL
Dosage Form:
NDC: 45802-453
Application: NDA020748
Effective: 20230725
Indications & Usage
INDICATIONS AND USAGE Adapalene Cream, 0.1% is indicated for the topical treatment of acne vulgaris.
Dosage & Administration
DOSAGE AND ADMINISTRATION Adapalene Cream, 0.1% should be applied to affected areas of the skin, once daily at nighttime. A thin film of the cream should be applied to the skin areas where acne lesions appear, using enough to cover the entire affected areas lightly. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of Adapalene Cream, 0.1%.
Contraindications
CONTRAINDICATIONS Adapalene Cream, 0.1% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the cream vehicle.
Warnings
Not available.
Adverse Reactions
ADVERSE REACTIONS In controlled clinical trials, local cutaneous irritation was monitored in 285 acne patients who used Adapalene Cream, 0.1% once daily for 12 weeks. The frequency and severity of erythema, scaling, dryness, pruritus and burning were assessed during these studies. The incidence of local cutaneous irritation with Adapalene Cream, 0.1% from the controlled clinical studies is provided in the following table: Incidence of Local Cutaneous Irritation with Adapalene Cream, 0.1% from Controlled Clinical Studies (N=285) None Mild Moderate Severe Erythema 52% (148) 38% (108) 10% (28) ‹1% (1) Scaling 58% (166) 35% (100) 6% (18) ‹1% (1) Dryness 48% (136) 42% (121) 9% (26) ‹1% (2) Pruritus (persistent) 74% (211) 21% (61) 4% (12) ‹1% (1) Burning/Stinging (persistent) 71% (202) 24% (69) 4% (12) ‹1% (2) Other reported local cutaneous adverse events in patients who used Adapalene Cream, 0.1% once daily included: sunburn (2%), skin discomfort-burning and stinging (1%) and skin irritation (1%). Events occurring in less than 1% of patients treated with Adapalene Cream, 0.1% included: acne flare, dermatitis and contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.