ADAPALENE AND BENZOYL PEROXIDE SWAB- adapalene and benzoyl peroxide gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF), BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)

Available from:

Biomes Pharmaceuticals

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adapalene and benzoyl peroxide swab 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. None Teratogenic Effects: Pregnancy Category C There are no well-controlled trials in pregnant women treated with adapalene and benzoyl peroxide. Animal reproduction studies have not been conducted with the combination or benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, adapalene and benzoyl peroxide should be used during pregnancy only if the potential benefit justifies the risk to the fetus. No teratogenic effects were observed in rats treated with oral doses of 0.15 to  5 mg  adapalene/kg/day, up to 25 times  (mg/m2/day) the  maximum recommended human dose (MRHD) of 2 grams  of adapalene and benzoyl peroxide. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of greater than or equal to 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively. Findings included

Product summary:

Adapalene and benzoyl peroxide swab 0.1% / 2.5% is supplied in the following size: 14 count use-of-use 1.2g swab        NDC 69150-001-14

Authorization status:

unapproved drug other

Summary of Product characteristics

ADAPALENE AND BENZOYL PEROXIDE SWAB- ADAPALENE AND BENZOYL PEROXIDE
GEL
BIOMES PHARMACEUTICALS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADAPALENE AND BENZOYL PEROXIDE GEL SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADAPALENE AND
BENZOYL PEROXIDE SWABS.ADAPALENE AND
BENZOYL PEROXIDE GEL 0.1% / 2.5% FOR TOPICAL USE
INITIAL U.S. APPROVAL:
INDICATIONS AND USAGE
Adapalene and benzoyl peroxide swab 0.1% / 2.5% is a combination of
adapalene, a retinoid, and benzoyl peroxide, and is
indicated for the topical treatment of acne vulgaris in patients 9
years of age and older. (1) (1)
DOSAGE AND ADMINISTRATION
Adapalene and benzoyl peroxide swab is not for oral, ophthalmic, or
intravaginal use. (2) Apply adapalene and benzoyl
peroxide swab to affected areas of the face and/or trunk once daily
after washing. Use swab amount for area of the face
(e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous
membranes. (2) (2)
DOSAGE FORMS AND STRENGTHS
Each gram of adapalene and benzoyl peroxide swab contains 1 mg (0.1%)
adapalene, USP and 25 mg (2.5%) benzoyl
peroxide, USP. (3) (3)
CONTRAINDICATIONS
None. (4) (4)
WARNINGS AND PRECAUTIONS
Ultraviolet Light and Environmental Exposure: Avoid exposure to
sunlight and sunlamps. Wear sunscreen when sun
exposure cannot be avoided. (5.1) Erythema, scaling, dryness,
stinging/burning, irritant and allergic contact dermatitis may
occur with use of adapalene and benzoyl peroxide swab and may
necessitate discontinuation. (5.2) (5)
ADVERSE REACTIONS
Most commonly reported adverse events (greater than or equal to 1%) in
patients treated with adapalene and benzoyl
peroxide swab were dry skin, contact dermatitis, application site
burning, application site irritation and skin irritation. (6) (6)
TO REPORT SUSPECTED AD