Label: ALCOHOL WIPES- hand sanitizing wipes cloth

  • 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 20, 2020

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

  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • Inactive ingredients

    Water

  • Purpose

    ANTISEPTIC;

  • WHEN USING

    THESE WIPES ARE MEANT FOR GENERAL CLEANSING.

  • Do not use

    DO NOT REPLACE WIPES USED FOR MEDICAL PROCEDURES.

  • STOP USE

    STOP USE: IF IRRITATION AND REDNESS DEVELOP. IFCONDITION CONTINUS, CONSULT YOUR HEALTH CARE PRACTITIONER.

  • 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.

  • Use

    FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.

  • Directions

    DIRECTIONS: UNFOLD TOWLETTE, WIPE HANDS, DISCARD AFTER USE.

  • Warnings

    FOR EXTERNAL USE ONLY. DO NOT REPLACE WIPES USED FOR MEDICAL PROCEDURES. THESE WIPES ARE MEANT FOR GENERAL CLEANSING. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME. IF EYES CONTACT OCCURS, FLUSH EYES WITH WATER. STORE AT ROOM TEMPERATURE 59F - 86 F.

  • Other information

    • STORE AT ROOM TEMPERATURE 59F - 86F.
  • Package Label - Principal Display Panel

    100 U 1 PAIL NDC:75163-003-01

    100 CLOTH LABEL

    200 U 1 PAIL NDC:75163-003-02

    200 CLOTH LABEL

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    hand sanitizing wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75163-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 U  in 1 U
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75163-003-01100 U in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    2NDC:75163-003-02200 U in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Zhuji Jianhe Paper Co., Ltd (554529241)
    Registrant - Zhuji Jianhe Paper Co., Ltd (554529241)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhuji Jianhe Paper Co., Ltd554529241manufacture(75163-003)