Label: ACNE WASH FACIAL CLEANSER TEA TREE OIL- salicylic acid liquid

  • 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 September 18, 2019

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  • PURPOSE

    Purpose

    Acne treatment

  • ACTIVE INGREDIENT

    Active Ingredient

    Salicylic Acid 2%

  • INDICATIONS & USAGE

    USAGE

    For the treatments of acne

  • DOSAGE & ADMINISTRATION

    Directions

    Wet face

    Gently massage product all over face for 20-30 seconds, avoiding eye area

    Rinse thoroughly and pat dry

    Cleanse twice a day.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed get medical help or contact a poison control center right away.

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

  • WARNINGS

    Warnings


    For external use only May stain some fabrics.
    When using this product and other typical acne medications at the same time or immediately following use of this product, dryness or irritation of the skin may be increased. If this occurs, only one medication should be used unless directed by a doctor

  • INACTIVE INGREDIENT

    WATER, SODIUM C14-16 SULFONATE, COCAMIDOPROPYL BETAINE, ACRYLATES COPOLYMER, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, FRAGRANCE, CITRIC ACID, ALOE BARBADENSIS LEAF JUICE, DISODIUM EDTA, SODIUM HYDROXIDE, D&C BLUE NO.1 MELALEUCA ALTERNIFOLIA TEA TREE LEAF OIL

  • PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    ACNE WASH FACIAL CLEANSER TEA TREE OIL 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-089
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 200 mL
    Inactive Ingredients
    Ingredient NameStrength
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-089-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/29/2016
    Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-089)
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