Label: ALCOHOL WIPES- alcohol cloth

  • NDC Code(s): 81079-002-01, 81079-002-02, 81079-002-03, 81079-002-04, view more
    81079-002-05, 81079-002-06
  • Packager: Shaoxing Elite Bio-Tech Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 22, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient(s)

    Alcohol 75% v/v

  • Purpose

    Antiseptic

  • Use

    For hand sanitizing to decrease bacteria on skin.

  • Warnings

    For external use only. Flammable: Keep away from fire or flame.

  • Do not use

    In children less than 2 months of age.

    On open skin wounds.

  • WHEN USING

    When using this product avoid contact with eyes and mouth. If in eyes，flush thoroughly with water.

  • STOP USE

    Discontinue use and contact a doctor if irritation and redness develop and conditions persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children unless under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Open the lid, tear open packet, remove wipe.

    Wet hands thoroughly with product and let hands air dry.

    Throw used wipe in trash.

    Do not flush.

  • Other information

    Store between 15-30 °C (59-86 °F).

    Avoid freezing and excessive heat above 40 °C (104 °F).

  • Inactive ingredients

    Water.

  • Package Label - Principal Display Panel

    NDC:81079-002-01

    10NDC:81079-002-02

    20NDC:81079-002-03

    40NDC:81079-002-04

    60NDC:81079-002-05

    80NDC:81079-002-06

    100

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81079-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81079-002-0138 mL in 1 BAG; Type 0: Not a Combination Product11/16/2020
    2NDC:81079-002-0276 mL in 1 BAG; Type 0: Not a Combination Product11/16/2020
    3NDC:81079-002-03153 mL in 1 BAG; Type 0: Not a Combination Product11/16/2020
    4NDC:81079-002-04230 mL in 1 BAG; Type 0: Not a Combination Product11/16/2020
    5NDC:81079-002-05307 mL in 1 BAG; Type 0: Not a Combination Product11/16/2020
    6NDC:81079-002-06384 mL in 1 BAG; Type 0: Not a Combination Product11/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)11/16/2020
    Labeler - Shaoxing Elite Bio-Tech Co.,Ltd. (546459425)
    Registrant - Shaoxing Elite Bio-Tech Co.,Ltd. (546459425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shaoxing Elite Bio-Tech Co.,Ltd.546459425manufacture(81079-002)
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