Label: GERMS OUT- 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 September 15, 2020

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  • Active Ingredient(s)

    Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    ANTIMICROBIAL

  • 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 fire or flame

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

  • Do not use

    Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

  • WHEN USING

    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 infestion get medical help or contact a Poison Control Center right away (1-800-222-1222) or 911.

  • 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 between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • Package Label - Principal Display Panel

    236 ml NDC: 79878-003-00

    236 ML Label

    3785 ml NDC: 79878-003-01

    3785 ML Label

    473 ml NDC: 79878-003-02

    label 473ml

    946 ml NDC: 79878-003-03

    label 946 ml

  • INGREDIENTS AND APPEARANCE
    GERMS OUT 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79878-003
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79878-003-00236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2020
    2NDC:79878-003-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2020
    3NDC:79878-003-02473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2020
    4NDC:79878-003-03946 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/24/2020
    Labeler - PENSEUR PRODUCTS GROUP LLC (117584143)
    Registrant - PENSEUR PRODUCTS GROUP LLC (117584143)
    Establishment
    NameAddressID/FEIBusiness Operations
    PENSEUR PRODUCTS GROUP LLC117584143manufacture(79878-003)
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