Label: 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN- isopropyl alcohol liquid

  • NDC Code(s): 58037-211-01, 58037-211-02
  • Packager: New Pride Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2023

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  • ACTIVE INGREDIENT

    Active ingredient (by volume)

    Isopropyl alcohol (70% concentrate)

  • PURPOSE

    Purpose

    topical antimicrobial

  • INDICATIONS & USAGE

    Uses

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

    Warnings

    For external use only

    • flammable, keep away from fire and flame
    • will produce serious gastric disturbances if taken internally
  • ASK DOCTOR

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

  • DO NOT USE

    When using this product

    • do not get into eyes or mucous membranes
    • use only in a well-ventilated area
  • STOP USE

    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

  • DOSAGE & ADMINISTRATION

    Directions

    • apply to skin directly of with clean gauze, cotton or swab
    • for rubbing apply liberally and rub with hands
  • SPL UNCLASSIFIED SECTION

    Other information

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

    Inactive ingredient

    Water, Methyl Salicylate, FD&C Blue #1, FD&C Yellow #5

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58037-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58037-211-01355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2023
    2NDC:58037-211-02473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00301/05/2023
    Labeler - New Pride Corp (884264198)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(58037-211)
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