Label: INTENSIVE FACE AND BODY ACNE TREATMENT- benzoyl peroxide gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 58876-107-36 - Packager: DR LIN SKINCARE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 11, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR/PHARMACIST
-
WHEN USING
When using this product
- avoid unnecessary sun exposure and use a sunscreen.
- avoid contact with eyes lips and mouth.
- avoid contact with hair and dyed fabrics, which may be bleached by this product.
- skin irritation may occur characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- wet area to be cleansed.
- apply small amount to skin.
- gently massage to create lather.
- rinse thoroughly and pat dry.
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to twice daily if needed or directed by a doctor.
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside, apply sunscreen after using this product.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
INTENSIVE FACE AND BODY ACNE TREATMENT
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58876-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) ALLANTOIN (UNII: 344S277G0Z) PANTHENOL (UNII: WV9CM0O67Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) BERGAMOT ORANGE (UNII: IET5D90X0D) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58876-107-36 180 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/11/2014 Labeler - DR LIN SKINCARE (622329980) Establishment Name Address ID/FEI Business Operations Westwood Laboratories Inc. 069926483 manufacture(58876-107) , pack(58876-107)