Label: HEALTH SMART 50% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN- isopropyl alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 14, 2020

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  • Active ingredient

    lsopropyl alcohol (50% concentrate)

  • Purpose

    topical antimicrobial

  • Uses

    • to decrease germs in minor cuts and scrapes.
    • helps relieve minor muscular aches due to exertion.
  • Warnings

    • For external use only.
    • Flammable, keep away from fire and flame.
    • Will produce serious gastric disturbances if taken internally.

    Ask a doctor before use if you have deep puncture wounds or serious burns.

    When using this product
    do not get into eyes or mucous membranes.
    use only in a well-ventilated area.

    Stop use and ask a doctor if condition persists or gets worse.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

  • Directions

    • apply to skin directly of with clean gauze, cotton or swab
    • for rubbing, apply liberally and rub with hands.
  • Other information

    • does not contain, nor is intended as a substitute for grain or ethyl alcohol.
    • keep bottle tightly closed.
  • Inactive ingredients

    Water, Methyl Salicylate, Laneth-75, FD&C Blue #1, FD&C Yellow #5.

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    HEALTH SMART 50% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73398-451
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL50 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73398-451-01354 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - SUHAN AEROSOLS (861140760)
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