O SKIN ACNE BENZOYL WASH- benzoyl peroxide lotion

O SKIN ACNE BENZOYL WASH by

Drug Labeling and Warnings

O SKIN ACNE BENZOYL WASH by is a Otc medication manufactured, distributed, or labeled by O SKIN CARE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

BENZOYL PEROXIDE  2.5%

PURPOSE

ACNE TREATMENT

USE:

FOR THE TREATMENT OF ACNE

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:

FOR EXTERNAL USE ONLY.

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

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT THE POISON CONTROL CENTER RIGHT AWAY.

INACTIVE INGREDIENTS:

WATER, SODIUM METHYL-2 SULFOLAURATE, COCAMIDOPROPYL HYDROXYSULTAINE, SODIUM LAURYL SULFOACETATE, COCAMIDOPROPYL BETAINE, DISODIUM 2-SULFOLAURATE, DECYLGLUCOSIDE POLYETHYLENE, SOYAMIDOPROPYL-DIMETHYLAMINE OXIDE, CAPRYLHYDROXAMIC ACID, PHENETHYL ALCOHOL, GLYCERIN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

O SKIN ACNE BENZOYL WASH 
benzoyl peroxide lotion

Product 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	part333D	05/01/2017

Labeler - O SKIN CARE LLC (021275401)

Establishment
Name	Address	ID/FEI	Business Operations
PRIVATE LABEL PARTNERS		046033481	manufacture(71421-102)