Label: PERSONAL CARE DEEP CLEANING ASTRINGENT- 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 April 12, 2018

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

  • Active Ingredient

    Salicylic Acid 0.5%

  • Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • Warnings

    For external use only Keep out of eyes ■ If contact with eyes occurs, immediately flush with water.

    Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor.

  • Keep out of reach of children

    If accidentally ingested seek medical help immediately or contact your local Poison Control Center.

  • Directions

    ■ use twice a day ■ wet face ■ apply to hands, add water and work into a lather ■ massage face gently,then rinse thoroughly.

  • Inactive Ingredients

    water (aqua), alcohol (24.5%), propylene glycol, glycerin, PEG-32, algae extract, DMDM hydantoin, dimethicone propyl PG-betaine, sodium citrate, aloe barbadensis leaf extract, benzophenone-4, fragrance, FD&C yellow No. 5.

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE  DEEP CLEANING ASTRINGENT
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72133-200-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/09/2018
    Labeler - Delta Brands & Products LLC (080999173)