Label: ALCOHOL WIPES- alcohol cloth

  • NDC Code(s): 77665-104-01, 77665-104-02
  • Packager: Guangzhou Baihua Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 7, 2024

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  • Purpose

    PURPOSE: ANTIMICROBIAL

  • Active Ingredient(s)

    ACTIVE INGREDIENT: ETHYL ALCOHOL 75%

  • Use

    USES: HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN.

  • Warnings

    WARNINGS: FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME

    ■ FOR EXTERNAL USE ONLY.

    ■ DO NOT USE IN OR NEAR THE EYES.

    IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.

    ■ STOP USE AND CONSULT WITH A PHYSICIAN IF IRRITATION DEVELOPS AND LASTS FOR MORE THAN 72 HOURS.

    ■ KEEP OUT OF REACH OF CHILDREN.

    ■ IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • Do not use

    ■ DO NOT USE IN OR NEAR THE EYES.

  • WHEN USING

    IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.

    ■ IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

  • STOP USE

    ■ STOP USE AND CONSULT WITH A PHYSICIAN IF IRRITATION DEVELOPS AND LASTS FOR MORE THAN 72 HOURS

  • KEEP OUT OF REACH OF CHILDREN

    ■ KEEP OUT OF REACH OF CHILDREN

  • Directions

    ■ DISPENSING. LIFT THE FRONT LID. OPEN PROTECTIVE SEAL. PULL OUT WIPE, RESEAL, AND CLOSE THE LID.

    ■ USE. WIPE HANDS THOROUGHLY.

    ■ DISPOSAL. DO NOT FLUSH.

    Directions of Use:
    1. Open the lid and slowly peel back label.2. Pull out wipes as needed.
    3. Reseal label to retain moisture.

  • Other information

    STORAGE. STORE AT ROOM TEMPERATURE.

  • Inactive ingredients

    Glycerol, Hydrogen Peroxide, RO pure water

  • Package Label - Principal Display Panel

    Alcohol Wipes(80pcs) 77665-104-01

    label

    Alcohol Wipes(20pcs) 77665-104-02

    Alcohol Wipes 20pcs

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77665-104
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77665-104-0180 mL in 1 PACKAGE; Type 0: Not a Combination Product07/18/2023
    2NDC:77665-104-0220 mL in 1 PACKAGE; Type 0: Not a Combination Product07/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/18/2023
    Labeler - Guangzhou Baihua Co., Ltd. (545015588)
    Registrant - Guangzhou Baihua Co., Ltd. (545015588)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Baihua Co., Ltd545015588manufacture(77665-104)