Label: OXY VOLCANIC CLAY ACNE WASH- salicylic acid cream

  • NDC Code(s): 10742-8338-1
  • Packager: The Mentholatum Company
  • 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 February 7, 2023

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  • Active ingredient

    Salicylic acid 2%

  • Purpose

    Acne treatment

  • Uses

    treats and helps prevent acne

  • Warnings

    For external use only

    When using this product

    • keep away from eyes. If contact occurs, flush thoroughly with water.
    • 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.

    If pregnant or breast-feeding,

    ask a health professional before use

    Keep out of reach of children.

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

  • Directions

    • wet face gently
    • gently massage cleanser onto skin, avoiding eye area
    • rinse thoroughly
  • Inactive ingredients

    bentonite, butylene glycol, ceteareth-20, cetearyl alcohol, cetostearyl alcohol, charcoal powder, cocamidopropyl betaine, cocos nucifera (coconut) oil, disodium cocoamphodiacetate, edetate disodium, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, fragrance, glycerin, hydroxypropyl starch phosphate, jojoba esters, kaolin, lecithin, menthol, methyl gluceth-20, panthenol, paraffin, potassium sorbate, purified water, silica, sodium benzoate, sodium laureth sulfate, trolamine, volcanic ash, xanthan gum

  • Questions?

    1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

  • Package/Label Principal Display Panel

    Oxy Volcanic Clay Acne Wash
  • INGREDIENTS AND APPEARANCE
    OXY VOLCANIC CLAY ACNE WASH 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8338
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    KAOLIN (UNII: 24H4NWX5CO)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8338-1142 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2018
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-8338)
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