Clinical Information
Gen. Code and Des.
74495 adapalene/benzoyl peroxide TOPICAL GEL W/PUMP 0.3 %-2.5%
GCN and Des.
39163 adapalene/benzoyl peroxide TOPICAL GEL W/PUMP 0.3 %-2.5%
Strength
0.3-2.5%
Dose Form
GEL WITH PUMP (GRAM)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.
Active Ingredients
1955 benzoyl peroxide 94360
5905 adapalene 106685409
Inactive Ingredients
2468 propylene glycol 57556
3785 edetic acid 60004
7543 sorbitan esters
EPIDUO - adapalene and benzoyl peroxide gel
Physicians Total Care, Inc.
1 INDICATIONS AND USAGE
EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
2 DOSAGE AND ADMINISTRATION
For topical use only; EPIDUO gel is not for oral, ophthalmic, or intravaginal use.
Apply a thin film of EPIDUO gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes.
3 DOSAGE FORMS AND STRENGTHS
Each gram of EPIDUO gel contains 1 mg (0.1%) adapalene and 25 mg (2.5%) benzoyl peroxide in a white to very pale yellow, opaque, aqueous based gel.
4 CONTRAINDICATIONS
None
5 WARNINGS AND PRECAUTIONS
5.1 Ultraviolet Light and Environmental Exposure
Exposure to sunlight, including sunlamps, should be minimized during the use of EPIDUO gel. Patients with high levels of sun exposure and those with inherent sensitivity to sun should exercise particular caution. Use of sunscreen products and protective apparel, (e.g., hat) are recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, may be irritating to patients under treatment with EPIDUO gel.
5.2 Local Cutaneous Reactions
Erythema, scaling, dryness, and stinging/burning may be experienced with use of EPIDUO gel. These are most likely to occur during the first four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Irritant and allergic contact dermatitis may occur. Depending upon the severity of these adverse reactions, patients should be instructed to use a moisturizer, reduce the frequency of the application of EPIDUO gel, or discontinue use. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of "waxing" as a depilatory method should be avoided on skin treated with EPIDUO gel.
Avoid concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes).
