Label: 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

    60patch in 1 cylinder NDC:78623-153-01

  • Active ingredient(s)

    alcohol 75% v/v purpose :antiseptic

  • purpose

  • Use

    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 thorough 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 irriation 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

    place enough product on hands to cover all surfaces,rub hands together until dry.

    supervise children under 6 years of age when using this product to avoid swallowing.

  • other information

  • inactive ingredients

  • package label principal display panel

    60pcst.jpg25ml in 1 cylinder NDC:78623-153-01

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78623-153
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78623-153-0125 mL in 1 CYLINDER; Type 0: Not a Combination Product06/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/02/2020
    Labeler - ningbo fareast industry co.,ltd (554535808)
    Registrant - ningbo fareast industry co.,ltd (554535808)
    Establishment
    NameAddressID/FEIBusiness Operations
    ningbo fareast industry co.,ltd554535808manufacture(78623-153)
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