Label: DEEP CLEANSING FOAMING ACNE SCRUB- salicylic acid liquid

  • NDC Code(s): 50157-609-12
  • Packager: Brands International Corporation
  • 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 22, 2023

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  • ACTIVE INGREDIENT

    Salicylic Acid 2.0%.

  • PURPOSE

    Acne Treatment

  • DOSAGE & ADMINISTRATION

    Direction

    • use twice daily
    • apply water to face and hands
    • dispense our product into hands and lather
    • apply to face, nose, and neck, and gently massage into skin
    • rinse thoroughly with tepid water
  • Indications and Use

    For management of Acne

  • WARNINGS

    For external use only

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

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops

  • WHEN USING

    When using this product

    • 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.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Hydroxymethyl cellulose, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Walnut Shell Powder, Vitamin E, Aloe Vera Leaf Extract.

  • OTHER SAFETY INFORMATION

    Store at room temperature.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    DEEP CLEANSING FOAMING ACNE SCRUB 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-609
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    BLACK WALNUT SHELL (UNII: J7DAA933PR)  
    VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-609-121270 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H02/22/2023
    Labeler - Brands International Corporation (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International Corporation243748238manufacture(50157-609)
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