Label: 75% DISINFECTANT 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 August 20, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Ethyl alcohol 75%

  • Purpose

    It has killing effect on Escherichia coli, Staphylococcus aureus, Candida albicans and natural bacteria (common bacteria in hospital infection).

  • Uses

    1. Human skin disinfection: Dip a cotton swab or cotton ball ( or spray) with an appropriate amount of disinfectant, and wipe the area to be treated 1-2 times for 1.5 minutes
    2. Disinfect the surface of the object: use a cotton swab or cotton ball (or spray) to wipe the surface of the object with an appropriate amount of disinfectant for 1.5 minutes.

  • Warnings

    1. This product is a disinfectant for external use and should not be taken orally.
    2. Please place it out of reach of children.
    3. This product is flammable and away from fire sources.
    4. Use with caution in alcohol allergies.
    5. After opening the product, it should be sealed in time to avoid volatilization

  • DO NOT USE

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  • When using this product

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  • STOP USE

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  • KEEP OUT OF REACH OF CHILDREN

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  • Directions

    1. This product is a disinfectant for external use and should not be taken orally.
    2. Please place it out of reach of children.
    3. This product is flammable and away from fire sources.
    4. Use with caution in alcohol allergies.
    5. After opening the product, it should be sealed in time to avoid volatilization

  • Other information

    Store in a cool, dry and ventilated room away from light
    Suitable for disinfection of human skin and surfaces.

  • Inactive ingredients

    Water 25%

  • Package Label - Principal Display Panel

    75879-002-01 60ml75879-002-03 100 ml75879-002-08 500ml75879-002-02 99ml75879-002-07 499ml75879-002-05 200ml75879-002-04 100ml75879-002-06 300ml

  • INGREDIENTS AND APPEARANCE
    75% DISINFECTANT ALCOHOL 
    75% disinfectant alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75879-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75879-002-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2020
    2NDC:75879-002-0299 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2020
    3NDC:75879-002-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2020
    4NDC:75879-002-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2020
    5NDC:75879-002-05200 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2020
    6NDC:75879-002-06300 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2020
    7NDC:75879-002-07499 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2020
    8NDC:75879-002-08500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/21/2020
    Labeler - FEELLIFE MEDICAL INC. (421264782)
    Registrant - FEELLIFE MEDICAL INC. (421264782)
    Establishment
    NameAddressID/FEIBusiness Operations
    FEELLIFE MEDICAL INC.421264782manufacture(75879-002)