Label: ISOPROPYL ALCOHOL 91 PERCENT- isopropyl alcohol liquid

  • NDC Code(s): 30400-505-01, 30400-505-02
  • Packager: Jell Pharmaceuticals Pvt. Ltd.
  • 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 October 5, 2021

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  • Active ingredient (by volume)

    Isopropyl alcohol (91% conc.)

  • Purpose

    First aid antiseptic

  • Uses

    • first aid to help prevent the risk of infection in minor cuts, scrapes and burns.
  • Warnings

    For external use only.

    • if taken  internally, serious gastic disturbance will result

    Flammable, keep away from fire or flame.

    • use only in a well-ventilated area; fumes may be toxic

    Ask a doctor before use if you have

    deep or puncture wounds, animal bites or serious burns

    When using this product

    • do not get into eyes
    • do not apply over large areas of the body
    • do not use longer than one week unless directed by a doctor

    Stop use and ask a doctor if

    condition persists or gets worse

    Keep out of reach of children.

    In case of ingestion, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean affected area
    • apply small amount of this product on the area 1-3 times daily
    • if bandaged, let dry first
    • may be covered with a sterile bandage
  • Other information

    • store at room temperature
    • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • Inactive ingredient

    purified water

  • Principal Display Panel

    91% Isopropyl Alcohol

    Antiseptic

    • Topical Antiseptic & Sanitizer
    • Antibacterial Cleansing Agent for Minor Cuts & Abrasions
    • Preparation of Skin Prior to an Injection

    For question or comments call 1-888-287-1915.

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY: Wal-Mart Stores, Inc.,

    Bentonville, AR 72716

  • Package Label

    Isopropyl Alcohol (91% conc.)
  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL  91 PERCENT
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30400-505
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL91 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30400-505-02473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/30/2014
    2NDC:30400-505-01946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/30/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/30/2014
    Labeler - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt Ltd.726025211manufacture(30400-505)
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