Label: BENZEFOAM ULTRA- benzoyl peroxide aerosol
- NDC Code(s): 0187-0201-10
- Packager: Bausch Health US, LLC
- 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 6, 2020
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- Do not use if you
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When using this product
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- skin irritation and dryness are 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.
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- avoid unnecessary sun exposure and use a sunscreen.
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- avoid contact with the eyes, lips, and mouth.
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- avoid contact with hair and dyed fabrics, which may be bleached by this product.
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- 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.
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- do not puncture or incinerate container. Contents under pressure.
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- do not expose to temperatures above 120°F (49°C).
- Stop use and ask a doctor if
- Keep Out of Reach of Children
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Directions
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- clean the skin thoroughly before applying this product
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- cover the entire affected area with a thin layer one to three times daily
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- rinse off after 2 minutes
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- 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
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- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
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- if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
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- to be used as a short contact application
- Other Information
- Inactive Ingredients
- Questions/comments?
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Package/Label Principal Display Panel - Carton
NDC: 0187-0194-10
BenzEFoam Ultra
benzoyl peroxide 9.8%Acne Treatment
Short Contact FoamFor Topical Use Only
Do Not Use in EyesWill not dispense entire contents.
Container is overfilled to guarantee
dispensing a minimum of 100 grams.Back Applicator Included
Ortho Dermatologics
Net Wt 3.5 OZ (100 g)
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INGREDIENTS AND APPEARANCE
BENZEFOAM ULTRA
benzoyl peroxide aerosolProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0187-0201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 9.8 g in 100 g Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) GLYCERIN (UNII: PDC6A3C0OX) NORFLURANE (UNII: DH9E53K1Y8) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) STEARETH-10 (UNII: FD0913P475) POLYSORBATE 60 (UNII: CAL22UVI4M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0187-0201-10 1 in 1 CARTON 02/06/2020 1 100 g in 1 CAN; 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 02/06/2020 Labeler - Bausch Health US, LLC (831922468) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals 001207208 MANUFACTURE(0187-0201)
