REPLENIX ACNE- benzoyl peroxide gel

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)

Disponível em:

Topiderm, Inc.

Via de administração:

TOPICAL

Tipo de prescrição:

OTC DRUG

Indicações terapêuticas:

Anti-acne - Topical acne medication.

Status de autorização:

OTC monograph final

Características técnicas

REPLENIX ACNE- BENZOYL PEROXIDE GEL
TOPIDERM, INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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REPLENIX ACNE GEL 10%
_DRUG FACTS_
ACTIVE INGREDIENT
Benzoyl Peroxide, USP 10%
PURPOS E
Anti-acne
US ES
Topical acne medication.
WARNINGS
WHEN USING THIS PRODUCT AVOID UNNECESSARY SUN EXPOSURE AND USE A
SUNSCREEN.
For external use only.
Keep away from eyes, lips, and mouth.
If irritation develops, discontinue use and consult a doctor.
Using other topical acne medications at the same time or immediately
following use of this product
may increase dryness or irritation of the skin. If this occurs,
consult a doctor.
May bleach fabrics.
KEEP OUT OF REACH OF CHILDREN. If swallowed, seek professional
assistance or contact a Poison
Control Center immediately.
DIRECTIONS
Cleanse the skin thoroughly before applying.
Apply a thin layer daily, then gradually increase to two or three
times daily.
If bothersome drying or peeling occurs, reduce applications.
IF GOING OUTSIDE, USE A SUNSCREEN. If irritation or sensitivity
develops, discontinue use of both
products and consult a doctor.
INACTIVE INGREDIENTS
Carbomer, Purified Water, Sodium Hydroxymethylglycinate, Sodium
Lauroyl Sarcosinate, Stearic Acid.
PRINCIPAL DISPLAY PANEL - 57 G TUBE LABEL
REPLENiX
®
®
ACNE SOLUTIONS
Acne Gel
Benzoyl Peroxide USP, 10%
Net wt. 2 oz. (57 g)
Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701
Topiderm, Inc.
REPLENIX ACNE
benzoyl peroxide gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:51326 -412
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BENZO YL PERO XIDE (UNII: W9 WZN9 A0 GM) (Benzo yl Pero xide - UNII:W9
WZN9 A0 GM)
Benzo yl Pero xide
10 0 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)
WATER (UNII: 0 59 QF0 KO0 R)
SO DIUM HYD