Label: ACNE CLEANSER- salycilic acid gel

  • 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 March 31, 2023

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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)  
    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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    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)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    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 finalM00604/04/2023
    Labeler - MONAT GLOBAL CORP (027036949)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oxygen Development137098492manufacture(78518-011)
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