Label: WITH75% ALCOHOL DISINFEGTANT 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 December 7, 2020

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  • SPL UNCLASSIFIED SECTION

    With75% ALCOHOL DISINFEGTANT Wipes

  • Active Ingredient(s)

    Alcohol 1mL/pcs. Purpose: Antiseptic

  • Purpose

    Antiseptic, With75% ALCOHOL DISINFEGTANT Wipes

  • Use

    With75% ALCOHOL DISINFEGTANT Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

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

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    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. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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

    • Wipe the surface of the skin and let it dry naturally.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    WATER
    Spunlace CLOTH

  • Package Label - Principal Display Panel

    305080

  • INGREDIENTS AND APPEARANCE
    WITH75% ALCOHOL DISINFEGTANT WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79459-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CLOTHIAPINE (UNII: Z05HCY0X1T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79459-101-0130 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    2NDC:79459-101-0250 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    3NDC:79459-101-0380 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Yiwu Beijie Biotechnology Co., Ltd. (554540045)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yiwu Beijie Biotechnology Co., Ltd.554540045manufacture(79459-101)
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