Label: AMORAY 70% ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol liquid

  • NDC Code(s): 51628-1015-1, 51628-1015-2
  • Packager: MY IMPORT USA INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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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 havedeep 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 ifcondition 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

  • PRINCIPAL DISPLAY PANEL

    alcohol-70

  • INGREDIENTS AND APPEARANCE
    AMORAY 70% ISOPROPYL RUBBING ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51628-1015
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51628-1015-1355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/11/2020
    2NDC:51628-1015-2473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00308/11/2020
    Labeler - MY IMPORT USA INC (195767988)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(51628-1015)
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