Label: ALCOHOL WIPES cloth

  • Category: HUMAN OTC DRUG LABEL

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 November 10, 2021

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  • ACTIVE INGREDIENT

    ALCOHOL (75% v/v)

  • PURPOSE

    ANTISEPTIC

  • USES

    HELP DECREASE BACTERIA ON THE HANDS.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

    AVOID CONTACT WITH EYES, IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER IMMEDIATELY.

    KEEP OUT OF REACH OF CHILDREN EXCEPT UNDER ADULT SUPERVISION.

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

    IF IRRITATION DEVELOPS, DISCONTINUE USE AND CONSULT A DOCTOR.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN EXCEPT UNDER ADULT SUPERVISION.

  • DIRECTIONS

    1、OPEN THE BARREL CAP;

    2、RIVE THE SEAL;

    3、PULL OUT THE WET TISSUE TOWEL THROUGH SMALL OPENING;

    4、COVER THE LIP;

    5、RUB THOROUGHLY OVER ALL SURFACES OF BOTH HANDS WITH THE WET WIPES;

    6、ALLOW TO DRY WITHOUT WIPING;

    7、DISPOSE OF WIPES IN TRASH AFTER USE. DOT NOT FLUSH.

  • OTHER INFORMATION

    STORE IN ROOM TEMPERATURE. AVOID DIRECT SUNLIGHT.

    SHELF LIFE: 2 YEARS

  • INACTIVE INGREDIENTS

    WATER (AQUA), TERT-BUTYL ALCOHOL, DENATONIUM BENZOATE

  • PRINCIPAL DISPLAY PANEL

    1 WIPES, NDC: 74658-013-01

    1wipes label

    75 WIPES, NDC: 74658-013-02

    75wipes label

    80 WIPES, NDC: 74658-013-03

    80wipes label

    100 WIPES, NDC: 74658-013-04

    100wipes label

    120 WIPES, NDC: 74658-013-05

    120wipes label

    130 WIPES, NDC: 74658-013-06

    130wipes label

    150 WIPES, NDC: 74658-013-07

    150wipes label

    180 WIPES, NDC: 74658-013-08

    180wipes label

    200 WIPES, NDC: 74658-013-09

    200wipes label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74658-013
    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
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    WATER (UNII: 059QF0KO0R)  
    DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74658-013-011 in 1 BAG10/10/2020
    14.3 mL in 1 PATCH; Type 0: Not a Combination Product
    2NDC:74658-013-0275 in 1 BOTTLE10/10/2020
    24.3 mL in 1 PATCH; Type 0: Not a Combination Product
    3NDC:74658-013-0380 in 1 BOTTLE10/10/2020
    34.3 mL in 1 PATCH; Type 0: Not a Combination Product
    4NDC:74658-013-04100 in 1 BOTTLE10/10/2020
    44.3 mL in 1 PATCH; Type 0: Not a Combination Product
    5NDC:74658-013-05120 in 1 BOTTLE10/10/2020
    54.3 mL in 1 PATCH; Type 0: Not a Combination Product
    6NDC:74658-013-06130 in 1 BOTTLE10/10/2020
    64.3 mL in 1 PATCH; Type 0: Not a Combination Product
    7NDC:74658-013-07150 in 1 BOTTLE10/10/2020
    74.3 mL in 1 PATCH; Type 0: Not a Combination Product
    8NDC:74658-013-08180 in 1 BOTTLE10/10/2020
    84.3 mL in 1 PATCH; Type 0: Not a Combination Product
    9NDC:74658-013-09200 in 1 BOTTLE10/10/2020
    94.3 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/10/2020
    Labeler - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)
    Registrant - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU XUELEI COSMETIC CO.,LTD.526885026manufacture(74658-013) , label(74658-013) , pack(74658-013)
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