Label: O SKIN ACNE BENZOYL WASH- benzoyl peroxide lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 71421-102-11 - Packager: O SKIN CARE LLC
- 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 December 16, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USE:
-
DIRECTIONS:
WET FACE. SQUEEZE A SMALL AMOUNT (DIME SIZE) INTO HANDS. APPLY TO FACE. GENTLY MASSAGE FOR 20 SECONDS. RINSE THOROUGHLY. USE MORNING AND NIGHT. IF BOTHERSOME DRYNESS, REDNESS, ITCHING OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY. STOP USE AND ASK A PHYSICIAN IF IRRITATION IS SEVERE.
- WARNINGS:
-
DO NOT USE
DO NOT USE THIS MEDICATION IF YOU ARE ALLERGIC TO BENZOYL PEROXIDE OR HAVE SENSITIVE SKIN.
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR. DISCONTINUE USE IF SKIN IRRITATION OCCURS.
WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER. AVOID UNNECESSARY SUN EXPOSURE. USE A SUNSCREEN, WHILE USING THIS PRODUCT AND FOR A WEEK AFTERWARDS. THIS PRODUCT MAY BLEACH HAIR AND FABRIC.
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENTS:
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
O SKIN ACNE BENZOYL WASH
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71421-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV) COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DISODIUM 2-SULFOLAURATE (UNII: 329M3829G2) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71421-102-11 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 05/01/2017 Labeler - O SKIN CARE LLC (021275401) Registrant - O SKIN CARE LLC (021275401)
