Medication Guide App

SAFEWAY ACNE TREATMENT

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 10g in 100g
Labeler: SAFEWAY INC.
NDC Code: 21130-826

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 FACTS

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?

1-888-723-3929

LABEL COPY

SAFEWAY  ACNE TREATMENT
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-826
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ALKYL (C12-15) BENZOATE 
PROPYLENE GLYCOL 
GLYCERYL MONOSTEARATE 
BENTONITE 
LAURETH-7 
CARBOMER 934 
POTASSIUM HYDROXIDE 
ALUMINUM HYDROXIDE 
POLYETHYLENE GLYCOL 600 
ISOPROPYL MYRISTATE 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:21130-826-0128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D06/06/2012
Labeler - SAFEWAY INC. (009137209)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIOperations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 06/2012
 
SAFEWAY INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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