Label: ACNE FREE BLACKHEAD REMOVING SCRUB 2 SALICYLIC ACID WITH CHARCOAL- 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 August 10, 2021

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Salicylic acid 2%

    Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • Warnings

    For external use only

    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.

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

  • Directions

    • wet hands and face
    • squeeze scrub into hands and rub together
    • apply to face and massage gently, avoiding contact with eyes. If contact occurs, rinse thoroughly with water.
    • rinse face

  • Inactive ingredients

    water, sodium laureth sulfate, perlite, sodium chloride, acrylates copolymer, sodium hydroxide, coco-betaine, cocamide MEA, glycerin, citric acid, trisodium ethylenediamine disuccinate, hydrogenated castor oil, propylene glycol, hydrogenated jojoba oil, iron oxides, charcoal powder, sorbitol, vaccinium myrtillus fruit extract, polyglycerin-10, polyglyceryl-10 myristate, polyglyceryl-10 stearate, sodium dehydroacetate, PPG-5-ceteth-20

  • Questions or comments?

    1-888-768-2913

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ACNE FREE BLACKHEAD REMOVING SCRUB 2 SALICYLIC ACID WITH CHARCOAL 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80861-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    PERLITE (UNII: 0SG101ZGK9)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    SORBITOL (UNII: 506T60A25R)  
    BILBERRY (UNII: 9P2U39H18W)  
    POLYGLYCERIN-10 (UNII: P9060O936A)  
    POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80861-012-01150 mL in 1 TUBE; Type 0: Not a Combination Product07/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/31/2018
    Labeler - AcneFree LLC (122237140)