Label: ACNE CLEANSER- benzoyl peroxide cream
- NDC Code(s): 55910-264-56
- Packager: Old East Main Co.
- 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 February 25, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- Do not use
-
When using this product
- 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.
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with the eyes, lips and mouth
- avoid contact with hair and dyed fabrics, which may be bleaced by this product
- skin irritation may occur, characterized by redness, burning, itching, peeling or possible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
- wet face. Gently massage all over face for 20-30 seconds avoiding the eyes. Rinse thoroughly and pat dry.
- because 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 daily 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
- Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas, during the first 3 days. If no discomfort occurs, follow the directions stated above.
- Other information
- Inactive ingredients
- Adverse reaction
- principal display panel
-
INGREDIENTS AND APPEARANCE
ACNE CLEANSER
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-264 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 104 mg in 10 g Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) PETROLATUM (UNII: 4T6H12BN9U) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ZINC LACTATE (UNII: 2GXR25858Y) STEARETH-2 (UNII: V56DFE46J5) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) xanthan gum (UNII: TTV12P4NEE) BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE DISODIUM (UNII: 7FLD91C86K) LAURETH-4 (UNII: 6HQ855798J) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM HYDROXIDE (UNII: 55X04QC32I) LACTIC ACID (UNII: 33X04XA5AT) MENTHOL (UNII: L7T10EIP3A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-264-56 141 g in 1 TUBE; Type 0: Not a Combination Product 02/18/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/18/2014 Labeler - Old East Main Co. (068331990) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55910-264) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55910-264)
