Label: BATH AND BEAUTY CHARCOAL ACNE SCRUB- 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 March 10, 2021

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  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic acid 1%

  • PURPOSE

    Purpose

    Acne treatment

  • INDICATIONS & USAGE

    Uses

    • clears up acne blemishes
    • penetrates pores to control acne blemishes
    • helps prevent new acne blemishes from forming
    • For the treatment of acne
  • WARNINGS

    Warnings

    For external use only.

  • WHEN USING

    When using this product

    • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    • skin irritation and dryness are 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet face
    • Squeeze product into hands
    • Massage over entire face and rinse thoroughly
    • Because excessive drying of gradually increase to 2 or 3 times daily if needed or as directed by a doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • STORAGE AND HANDLING

    Other information

    store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Glycerin, Sodium laureth Sulfate, Cocamidopropyl Betaine, Sorbitol,  Synthetic Wax, Microcrystalline Wax, Charcola Powder , Xanthan gum, fragrance, Sodium hydroxide, menthol, polyquaternium-39, charcoal powder, Disodium EDTA, Iodopropynyl Butylcarbamate,  Sodium Benzoate

  • PRINCIPAL DISPLAY PANEL

    4

  • INGREDIENTS AND APPEARANCE
    BATH AND BEAUTY   CHARCOAL ACNE SCRUB
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76772-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.3 g  in 91 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: X2NH1K9F8K)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MENTHOL (UNII: L7T10EIP3A)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76772-025-9191 g in 1 TUBE; Type 0: Not a Combination Product03/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/10/2021
    Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
    Registrant - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
    Establishment
    NameAddressID/FEIBusiness Operations
    TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI533120570manufacture(76772-025)
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