Label: SIGNATURE CARE ACNE MEDICATION- benzoyl peroxide gel
- NDC Code(s): 21130-730-16, 21130-730-17
- Packager: SAFEWAY, INC.
- 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 May 21, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- DO NOT USE
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When using this product
- avoid contact with the eyes, lips, and mouth
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with hair and dyed fabrics which may be bleached by this product
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Clean the skin thoroughly before applying this product
- Cover the entire affected area with a thin layer one to three times daily
- Becasue excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day
- If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIGNATURE CARE ACNE MEDICATION
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-730 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) EDETATE DISODIUM (UNII: 7FLD91C86K) HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) LAURETH-4 (UNII: 6HQ855798J) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-730-17 1 in 1 CARTON 12/08/2014 1 NDC:21130-730-16 28.3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/08/2014 Labeler - SAFEWAY, INC. (009137209) Registrant - FRUIT OF THE EARTH, INC. (079559467) Establishment Name Address ID/FEI Business Operations FRUIT OF THE EARTH, INC. 080086802 manufacture(21130-730)