Label: ACNE CLEANSER- salycilic acid gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 23, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient

    Salicylic Acid 2.00%

  • PURPOSE

    Purpose

    Acne Treatment

  • INDICATIONS & USAGE

    Uses

    • For the treatment of acne
    • Helps prevent new acne blemishes from forming
  • WARNINGS

    For external use only

    When using this product

    • skin irritation and dryness are more likely to occur if you use another topicalk acne medication at the same time. If irriatation occurs, only use one topical acne treatment at a time.
    • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right immediately.

  • Directions

    Directions

    • Shake well before use
    • Start with damp skin
    • Apply small amount onto your fingertips and emulsify
    • Gently cleanse the skin using circular motions.
    • Rinse with warm water and gently pat the skin dry
    • Follow with your MONAT skincare Routine
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Sodium Cocoyl Glutamate, Propanediol, Sorbeth-230 Tetraoleate, Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Sodium Cocoyl Isethionate, PEG-120 Methyl Glucose Dioleate, Niacinamide, Cocamide MIPA, Glycerin, Coconut Acid, Sodium Isethionate, Sodium PCA, Maclura Cochinchinensis Leaf Prenylflavonoids, Glycol Distearate, Laureth-4, Sodium Chloride, Sodium Benzoate, Potassium Sorbate, Polyquaternium-10, Decyl Glucoside, Sorbitan Laurate, Isopropyl Alcohol.

  • Questions or Comments

    Questions or comments?

    Toll-free number 1-800-878-1978

  • PRIMARY PACKAGE

    Primary Package

  • OUTER PACKAGE

    Outer packageSECONDARY-OUTER PACKAGE

  • INGREDIENTS AND APPEARANCE
    ACNE CLEANSER 
    salycilic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78518-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    LAURETH-4 (UNII: 6HQ855798J)  
    SODIUM ISETHIONATE (UNII: 3R36J71C17)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    DECYL GLUCOSIDE, .ALPHA.- (UNII: 47YY6O286H)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    COCONUT ACID (UNII: 40U37V505D)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MACLURA COCHINCHINENSIS WHOLE (UNII: X083FY34PH)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78518-011-011 in 1 CARTON04/04/2023
    1120 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00604/04/2023
    Labeler - MONAT GLOBAL CORP (027036949)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oxygen Development137098492manufacture(78518-011)
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