Label: 75%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 August 26, 2020

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  • SPL UNCLASSIFIED SECTION

    75%ALCOHOL WIPES

  • Active Ingredient(s)

    Alcohol 4.75g/pcs. Purpose: Antiseptic

  • Purpose

    Antiseptic, 75%ALCOHOL WIPES

  • Use

    75%ALCOHOL 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

    purified water USP

  • Package Label - Principal Display Panel

    308050106040

  • INGREDIENTS AND APPEARANCE
    75%ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80292-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL4.75 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80292-101-0110 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    2NDC:80292-101-0230 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    3NDC:80292-101-0340 in 1 BOX; Type 0: Not a Combination Product03/30/2020
    4NDC:80292-101-0450 in 1 BOX; Type 0: Not a Combination Product03/30/2020
    5NDC:80292-101-0560 in 1 BOX; Type 0: Not a Combination Product03/30/2020
    6NDC:80292-101-0680 in 1 BOX; 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 - Guangzhou Guangsan Biopharma Co., Ltd. (554538823)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Guangsan Biopharma Co., Ltd.554538823manufacture(80292-101)
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