Label: 70% ISOPROPYL ALCOHOL- 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 March 10, 2021

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  • SPL UNCLASSIFIED SECTION

    This is a first aid antiseptic. It is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

    1. Isopropyl Alcohol (70%, v/v) in an aqueous solution
    2. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients.

  • Active Ingredient(s)

    Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic.

  • Use

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

  • Warnings

    For external use only. If taken internally, serious gastric disturbances will result. Flammable. Keep away from heat or flame. Use only in a well-ventilated area; fumes may be toxic.

  • Do not use

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

    When using this product do not get in eyes


    do not apply over large areas of the body

    do not use longer than one week unless directed by a doctor

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, 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 ingredients

    purified water

  • Package Label - Principal Display Panel

    79481-0012-1946 ml NDC: 79481-0012-1

  • INGREDIENTS AND APPEARANCE
    70% ISOPROPYL ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0012
    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:79481-0012-1946 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Meijer (006959555)
    Registrant - Streamline Polymers (117054225)
    Establishment
    NameAddressID/FEIBusiness Operations
    Streamline Polymers117054225manufacture(79481-0012)
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