Label: ALCOHOL WIPES 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 10, 2020

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  • Active Ingredient(s)

    Alcohol 75% v/v

  • Purpose

  • Use

    Wipe surface to hel[P redu1Je bacteria that can potientially cause disease.

  • Warnings

  • Do not use

    In chilldren less than 2 months of age. On open skin wounds

  • WHEN USING

    Keep out of eyes, ears, and mouth. In case of contact witih eyes, rinse eyes thoroughly with water.

  • STOP USE

    if irritation or rash occurs. These may be sign of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    if swallowed, get medical help or contact a Poison control Genter right way.

  • Directions

    Rermove and unfold wipe
    Wipe surface thoroughly
    Dispose of used wipe in trash, do not flush

  • Other information

    Store between 50-86°F(15-30°C)
    Avoid Freezing and excessive heat above 104°F(40°c)

  • Inactive ingredients

    Purified water

  • Package Label - Principal Display Panel

    77909-021-01 80P

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77909-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77909-021-0180 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 - Huihao Medical Technology (Zhejiang) Co., Ltd (541292810)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huihao Medical Technology (Zhejiang) Co., Ltd541292810manufacture(77909-021)
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