Label: FOAMING ACNE SCRUB FOR A CLEANER, CLEARER COMPLEXION- salicylic 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 December 18, 2018

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  • PURPOSE

    Purpose

    Acne treatment

  • ACTIVE INGREDIENT

    Active Ingredient

    Salicylic Acid 2%

  • DOSAGE & ADMINISTRATION

    Directions

    • Use twice daily
    • Apply water to face and hands
    • Dispense our product into hands and lather
    • Apply to face, nose area and neck and gently massage into skin
    • Rinse thoroughly with tepid water

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

  • INACTIVE INGREDIENT

    WATER, SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL BETAINE, ACRYLATES COPOLYMER, PROPYLENE GLYCOL, SODIUM CHLORIDE, SODIUM LAURYL SULFATE, JUGLANS REGIA (WALNUT) SHELL POWDER, FRAGRANCE, SODIUM HYDROXIDE, DISODIUM EDTA, DMDM HYDRONTOIN, CIRTIC ACID, TOCOPHERYL ACETATE, YELLOW 5, RED 33

  • WARNINGS

    Warnings

    For external use only

    When using this product

    • Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, oinly use one topical acne medication at a time.
    • Avoid contact with eyes. If contact occurs, rinse thoroughly with water
  • INDICATIONS & USAGE

    Use

    • For the management of acne
  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FOAMING ACNE SCRUB  FOR A CLEANER, CLEARER COMPLEXION
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-3038
    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
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    JUGLANS REGIA SHELL (UNII: PJ10MT7VKA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    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:33992-3038-199 g in 1 BOTTLE; Type 0: Not a Combination Product12/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/16/2018
    Labeler - Greenbrier International Inc. (610322518)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(33992-3038)
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