Label: ANTIBACTERIAL ALCOHOL WIPES- alcohol 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 January 6, 2021

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  • Active Ingredient(s)

    EthylAlcohol 80%. Purpose: Antibacterial

  • Purpose

    Antibacterial, Hand Sanitizer

  • Use

    For handwashing to decrease bacteria on skin.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • on children less than 2 months of age
    • on open skin wounds
    • over large areas of the body or if you are allergic to any of these ingredients.

  • WHEN USING

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

  • 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

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

  • Directions

    • To use, pull out wipe and reseal container to maintain moisture.
    • Unfold cloth and rub thoroughly over all surfaces of both hands. Use only once and dispose of wipein a trash receptacle.
    • Do not flush.
    • Rub hands together briskly to dry.

  • Other information

    • Store between 59-86 °F (15-30 °C)
    • Avoid freezing and excessive heat
    • Dispose of contents/container responsibly
  • Inactive ingredients

    Water, Glycerin.

  • Principal Display Panel 450 units

    Main Label

  • 80 each Sanitizer Wipes

    Urigel Wipes 80 each80 Each NDC: 80924-110-01

  • 100 Each Sanitizer Wipes

    Urigel Wipes 100 each100 Each NDC:80924-110-02

  • 450 Sanitizer Wipes

    Urigel Wipes 450 each450 Each NDC:80924-110-03

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80924-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80924-110-03450 g in 1 CANISTER; Type 0: Not a Combination Product10/30/2020
    2NDC:80924-110-0180 g in 1 CANISTER; Type 0: Not a Combination Product10/01/2020
    3NDC:80924-110-02100 g in 1 CANISTER; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2020
    Labeler - Urigel (117688244)
    Registrant - Urigel Inc (117688244)
    Establishment
    NameAddressID/FEIBusiness Operations
    Antisépticos de México, S.A. de C.V.951576637manufacture(80924-110)
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