Label: 70% 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 January 13, 2022

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  • SPL UNCLASSIFIED SECTION

    This is a first aid antiseptic. The product 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

    Use(s) helps prevent the risk of infection in: minor cuts, scrapes, burns

  • Warnings

    For external use only. Flammable. Keep away from fire or flame, heat, spark, electrical

  • WHEN USING

    When using this product keep out of eyes, do not inhale, do not apply over large areas of the body, do not use longer than 1 week.

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

  • Other information

    • does not contain nor is intended as a substitute for grain or ethyl alcohol
    • will produce serious gastric disturbances if taken internally
  • Inactive ingredients

    purified water USP

  • Package Label - Principal Display Panel

    946 mL NDC: 74793-0008-1946 ml NDC: 74793-0008-1

  • INGREDIENTS AND APPEARANCE
    70% ISOPROPYL ALCOHOL 
    70% isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74793-0008
    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) 30 mL  in 100 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74793-0008-1946 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/15/2020
    Labeler - Streamline Polymers LLC (117054225)
    Registrant - Streamline Polymers LLC (117054225)
    Establishment
    NameAddressID/FEIBusiness Operations
    Streamline Polymers LLC117054225manufacture(74793-0008)
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