Label: DG BODY TONIC- 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 March 3, 2015

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  • ACTIVE INGREDIENT

    SALICYLIC ACID 2.0%

    PURPOSE

    ACNE TREATMENT

  • USES

    FOR THE TREATMENT OF ACNE

  • WARNINGS

    FOR EXTERNAL USE ONLY

    • FLAMMABLE
    • KEEP AWAY FROM FIRE OR HEAT SOURCE

    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

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

    STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

  • DIRECTIONS

    • CLEANSE SKIN THOROUGHLY
    • MOISTEN A COTTON BALL WITH PRODUCT AND COVER AFFECTED AREA ONE TO THREE TIMES DAILY
    • DUE TO EXCESSIVE DRYING OF THE SKIN, START WITH ONE APPLICATION DAILY, INCREASING TO 2 OR 3 IF NEEDED OR AS DIRECTED BY A PHYSICIAN
    • IF PEELING OCCURS, REDUCE USE TO ONCE A DAY OR EVERY OTHER DAY
  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE

  • INACTIVE INGREDIENTS

    WATER (AQUA), ALCOHOL DENAT., ISOCETETH-20, FRAGRANCE (PARFUM), DIMETHICONE PROPYL PG-BETAINE, BENZOPHENONE-4, RED 4 (CI 14700), DENATONIUM BENZOATE

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    DG BODY  TONIC
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-101
    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)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-101-08237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/02/2015
    Labeler - DOLGENCORP INC (068331990)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(55910-101)
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