Label: AVENE CLEANANCE ACNE MEDICATED CLEARING TREATMENT- benzoyl peroxide liquid
- NDC Code(s): 64760-776-01, 64760-776-02
- Packager: Pierre Fabre USA 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 3, 2023
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- Drug Facts
- Purpose
- Active Ingredient
- Uses
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Warnings
For external use only.
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 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.
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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.
because excessive dry of the skin may occur, start with one application daily, then gradually increase to two or three times daily 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.
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Inactive Ingredients
Water (aqua), propanediol, dimethyl isosorbide, glycerin, 1,2-hexanediol, acrylamide/sodium acryloyldimethyllurate copolymer, isohexadecane, hydroxyacetophenone, hylocereus undatus fruit extract, polysorbate 80, polyglyceryl-2 isostearate, xanthan gum, sodium citrate, trisodium ethylenediamine disuccinate, citric acid, diethylhexyl sodium sulfosuccinate, carbomer, sodium hydroxide, hyaluronic acid, ethylhexylglycerin, morinda citrifolia extract, phenoxyethanol, dimethicone, sodium metabisulfite, peg-40 stearate, silica, sorbitan stearate, tocopherol
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INGREDIENTS AND APPEARANCE
AVENE CLEANANCE ACNE MEDICATED CLEARING TREATMENT
benzoyl peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64760-776 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5.5 mg in 40 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPANEDIOL (UNII: 5965N8W85T) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) GLYCERIN (UNII: PDC6A3C0OX) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS) HYLOCEREUS UNDATUS FRUIT (UNII: WUG58TD53X) POLYSORBATE 80 (UNII: 6OZP39ZG8H) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM METABISULFITE (UNII: 4VON5FNS3C) CARBOMER 1342 (UNII: 809Y72KV36) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYALURONIC ACID (UNII: S270N0TRQY) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE (UNII: 92RU3N3Y1O) PEG-40 STEARATE (UNII: ECU18C66Q7) HYDRATED SILICA (UNII: Y6O7T4G8P9) TOCOPHEROL (UNII: R0ZB2556P8) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) MORINDA CITRIFOLIA FRUIT (UNII: 7829X3G2X5) PEG-20 SORBITAN STEARATE (UNII: HD40WR33LC) ISOHEXADECANE (UNII: 918X1OUF1E) POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC) DIHEXYL SODIUM SULFOSUCCINATE (UNII: 7YY1T561V4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64760-776-01 1 in 1 CARTON 05/30/2023 1 5 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:64760-776-02 1 in 1 CARTON 05/30/2023 2 40 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 05/30/2023 Labeler - Pierre Fabre USA Inc. (117196928) Registrant - Pierre Fabre USA Inc. (117196928)
