Label: EQUATE BEAUTY- salicylic acid soap

  • 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 July 28, 2022

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  • ACTIVE INGREDIENT

    Salicylic Acid

  • PURPOSE

    Acne treatment

  • INDICATIONS & USAGE

    Use: For the treatment of acne

  • WARNINGS

    • For external use only.
    • Flammable
    • Keep away form source of heat or fire

    Ask doctor or pharmacist before use

    Ask doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless otherwise
    directed by a doctor.

    When using this product

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water for 15 minutes.

    Stop use and ask a doctor

    Stop use and ask a doctor if irritation, dryness or redness develops and lasts. Ask doctor before use if pregnant/breastfeeding.

    Keep out of reach of children.

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    New Users: Apply to small area before use to test for sensitivity, If no discomfort occurs, apply to affected area and rinse off. Start with one application and gradually increase to 2-3 times daily if needed or as directed by physician.

  • Other Information

    Store at room temperature.

  • Inactive Ingredients

    Water, Alcohol Denat, Isoceteth-20, Fragrance (Parfum), Dimethicone Propyl PG-Betaine, Benzophenone-4, Red 4

  • PDP 03

    PDP-03

  • INGREDIENTS AND APPEARANCE
    EQUATE BEAUTY 
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-139
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2000 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SULISOBENZONE (UNII: 1W6L629B4K)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    DIMETHICONE PROPYL PG-BETAINE (UNII: OB83A4S9K9)  
    ALCOHOL (UNII: 3K9958V90M)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-139-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00607/19/2022
    Labeler - WALMART INC (051957769)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Heath and Beauty Care Inc.201901209manufacture(79903-139)
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