Label: AVENE CLEANANCE ACNE MEDICATED CLEARING GEL CLEANSER- salicylic acid liquid

  • NDC Code(s): 64760-775-01, 64760-775-02
  • 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 1, 2023

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  • Drug Facts

  • Purpose

    Acne Medication

  • Active Ingredient

    Salicylic Acid 2%

  • Uses

    For the treatment of acne.

  • 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.

    When using this product

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply morning and evening on a skin previously moistened with water.

    Gently massage, avoiding the eye area.

    Rinse thoroughly then dry.

  • Inactive Ingredients

    Water (aqua), sodium cocoyl isethionate, cocamidopropyl hydroxysultaine, propanediol, stearyl alcohol, coco-glucoside, sodium lauroyl sarcosinate, betaine, glyceryl laurate, sodium chloride, glycerin, cetearyl olivate, hydroxypropyl methylcellulose, sodium benzoate, saccharide isomerate, sorbitan olivate, hydroxypropyl guar hydroxypropyltrimonium chloride, xanthan gum, trisodium ethylenediamine disuccinate, potassium sorbate, lactobacillus ferment lysate, citric acid, sodium citrate, acrylates copolymer

  • Questions or comments?

    Visit www.aveneusa.com or call toll-free

    1-866-41-AVENE (28363)

  • Package Label

    EAU THERMALE

    Avene

    LABORATORIE DERMATOLOGIQUE

    CLEANANCE

    ACNE

    MEDICATED CLEARING GEL CLEANSER

    ACNE MEDICATED GEL CLEANER [SALICYLIC ACID 2%]

    FOR OILY, ACNE-PRONE, SENSITIVE SKIN

    FACE AND BODY

    HELPS CLEAR AND PREVENT NEW ACNE BLEMISHES AND BLACKHEADS.

    MAINTAINS A HEALTHY, BALANCED SKIN.

    200 ML

    6.7 FL. OZ.

    Avene Cleanance Acne Medicated Clearing Gel Cleanser

  • INGREDIENTS AND APPEARANCE
    AVENE CLEANANCE ACNE MEDICATED CLEARING GEL CLEANSER 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-775
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 200 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPANEDIOL (UNII: 5965N8W85T)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    BETAINE (UNII: 3SCV180C9W)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64760-775-011 in 1 CARTON05/30/2023
    125 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:64760-775-021 in 1 CARTON05/30/2023
    2200 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00605/30/2023
    Labeler - Pierre Fabre USA Inc. (117196928)
    Registrant - Pierre Fabre USA Inc. (117196928)
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