SAFEWAY ACNE TREATMENT- benzoyl peroxide cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

BENZOYL PEROXIDE 10%

PURPOSE

ACNE MEDICATION

USES

FOR THE TREATMENT AND PREVENTION OF ACNE PIMPLES.

WARNINGS

FOR EXTERNAL USE ONLY. SUNSCREEN ALERT: AVOID UNNECESSARY SUNSCREEN EXPOSURE BY USING A SUNSCREEN.

DO NOT USE IF

YOU HAVE VERY SENSITIVE SKIN OR ARE SENSITIVE TO BENZOYL PEROXIDE OR IF YOU ARE TAKING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES, LIPS AND MOUTH. AVOID CONTACT WITH HAIR OR DYED FABRICS, INCLUDING CARPET AND CLOTHING WHICH MAY BE BLEACHED BY THIS PRODUCT. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

SKIN IRRITATION, REDNESS, BURNING, ITCHING, PEELING OR SWELLING OCCURS AND LASTS. MILD IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING MEDICATION. COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER 1 TO 3 TIMES A DAY. START WITH 1 APPLICATION DAILY AND GRADUALLY INCREASE TO 2 TO 3 TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR. IF PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY. WHEN GOING OUTSIDE, USE A SUNSCREEN. ALLOW CREAM TO DRY AND FOLLOW DIRECTIONS IN THE SUNSCREEN LABELING. IF IRRITATION DEVELOPS, DISCONTINUE USE OF BOTH PRODUCTS AND CONSULT A DOCTOR.

OTHER INFORMATION

KEEP CAP TIGHTLY CLOSED. STORE AT CONTROLLED ROOM TEMPERATURE 20-25C (68-77F).

INACTIVE INGREDIENTS:

WATER (AQUA), C12-15 ALKYL BENZOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SE, BENTONITE, LAURETH-7, CARBOMER, ALUMINUM HYDROXIDE, PEG-12, ISOPROPYL MYRISTATE, METHYLPARABEN, PROPYLPARABEN.

QUESTIONS OR COMMENTS?

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LABEL COPY

INGREDIENTS AND APPEARANCE

SAFEWAY  ACNE TREATMENT
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-826
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BENTONITE (UNII: A3N5ZCN45C)
LAURETH-7 (UNII: Z95S6G8201)
CARBOMER 934 (UNII: Z135WT9208)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-826-01	28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333D	06/06/2012

Labeler - SAFEWAY INC. (009137209)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture