Label: ZAPZYT ACNE WASH CLEANSER- salicylic acid gel

  • NDC Code(s): 0295-9055-25
  • Packager: Denison Pharmaceuticals, 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 November 8, 2022

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  • Active Ingredient

    Salicylic Acid 2%

  • Purpose

    For the treatment of acne.

  • Warnings

    For external use only.

    Avoid contact with eyes. If contact occurs, flush thoroughly with water.

    using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a physician.

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    For the treatment of acne.

  • Directions

    • use twice daily
    • apply to hands
    • add water
    • massage gently to the affected area
    • rinse thoroughly
  • Other information

    • Store at room temperature 15º-30ºC (59º-86ºF).
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Flower Extract, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, PEG-120 Methyl Glucose Dioleate, Propylene Glycol, Purified Water, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Sodium Hydroxide

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    ZAPZYT ACNE WASH CLEANSER 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    CHAMOMILE (UNII: FGL3685T2X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-9055-25177 g in 1 TUBE; Type 0: Not a Combination Product11/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/08/2022
    Labeler - Denison Pharmaceuticals, LLC (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(0295-9055)
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