Label: 95% MEDICAL 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 December 17, 2020

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  • Active Ingredient(s)

    Ethanol 95%(V/V)

  • Purpose

    Antiseptic

  • Use

    Used to kill Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans and other microorganisms.

  • Warnings

    [Matters needing attention]
    1.This product is for external use and should not be taken orally;
    2.This product should be kept out of the reach of children;
    3.This product is flammable and should be kept away from sources of ignition

    [Taboo]
    This product is not suitable for disinfecting the surface off at-soluble objects, and should be used with caution for those who are allergic to alcohol.

  • Do not use

    /

  • WHEN USING

    1.It is suitable for disinfection of the surface of objects and the surface of human skin.
    2.Take this product to wipe the surface of objects or the surface of human skin directly.Or use a medical cotton swab(or cotton ball) dipped in a little product to wipe.Act just for three minutes.

  • 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

    /

  • Directions

    Perennial exposure to high concentrations of this product can cause irritation of the nose, eyes, and mucous membranes as well as headache, dizziness, fatigue, irritability, tremor, nausea, etc.

  • Other information

    The temperature of the warehouse should not exceed 30℃, keep the container seal

  • Inactive ingredients

    Purified water 5%(V/V)

  • Package Label - Principal Display Panel

    BOTTLE 80874-002-01 0.4065kg

    BOTTLE 80874-002-01 0.4065kg

    DRUM 80874-002-02 20kg

    DRUM 80874-002-02 20kg

    DRUM 80874-002-03 165kg

    DRUM 80874-002-03 165kg

    DRUM 80874-002-04 800kg

    DRUM 80874-002-04 800kg

  • INGREDIENTS AND APPEARANCE
    95% MEDICAL ALCOHOL 
    95% medical alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80874-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL95 kg  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80874-002-010.4065 kg in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:80874-002-04800 kg in 1 DRUM; Type 0: Not a Combination Product03/30/2020
    3NDC:80874-002-0220 kg in 1 DRUM; Type 0: Not a Combination Product03/30/2020
    4NDC:80874-002-03165 kg in 1 DRUM; 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 - Xinxiang Xianfeng Medicine New Material Co., Ltd. (407962189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xinxiang Xianfeng Medicine New Material Co., Ltd.407962189manufacture(80874-002)
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