Label: THE ORDINARY SALICYLIC ACID 2% SOLUTION- 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 November 29, 2022

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  • ACTIVE INGREDIENT

    Salicylic Acid (2%)

  • PURPOSE

    Acne Treatment

  • DOSAGE & ADMINISTRATION

    clean skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    acne

  • INACTIVE INGREDIENT

    Cocamidopropyl Dimethylamine, Chlorphenesin, Citric Acid, Hydroxyethylcellulose, Phenoxyethanol, Polysorbate 20, Saccharide Isomerate, Sodium Citrate, Sodium Hydroxide, Water.

  • WARNINGS

    Warnings

  • PRINCIPAL DISPLAY PANEL

    Principle Image

  • INGREDIENTS AND APPEARANCE
    THE ORDINARY SALICYLIC ACID 2% SOLUTION 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72208-211
    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
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72208-211-011 in 1 BOX02/25/2022
    130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00601/15/2022
    Labeler - Deciem (203133665)
    Establishment
    NameAddressID/FEIBusiness Operations
    HK Kolmar Canada, Inc243501959analysis(72208-211) , manufacture(72208-211) , pack(72208-211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crystal Claire Cosmetics Inc.205493484analysis(72208-211) , label(72208-211) , manufacture(72208-211) , pack(72208-211)
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