Active Ingredient
BENZOYL PEROXIDE 10%
The following Structured Product Label (SPL) was submitted to the FDA by Safeway Inc. for the product Safeway (NDC 21130-826). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use if, when using this product, stop using this product and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
BENZOYL PEROXIDE 10%
ACNE MEDICATION
FOR THE TREATMENT AND PREVENTION OF ACNE PIMPLES.
FOR EXTERNAL USE ONLY. SUNSCREEN ALERT: AVOID UNNECESSARY SUNSCREEN EXPOSURE BY USING A SUNSCREEN.
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.
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.
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.
IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
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.
KEEP CAP TIGHTLY CLOSED. STORE AT CONTROLLED ROOM TEMPERATURE 20-25C (68-77F).
WATER (AQUA), C12-15 ALKYL BENZOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SE, BENTONITE, LAURETH-7, CARBOMER, ALUMINUM HYDROXIDE, PEG-12, ISOPROPYL MYRISTATE, METHYLPARABEN, PROPYLPARABEN.
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