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 November 6, 2020

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  • DRUG FACTS:

  • Active Ingredients

    75% Ethanol Alcohol

    Purpose

    Antibacterial

  • Inactive Ingredient:

    pure water

  • DIRECTIONS:

    Open lid and pull tab. Pull out one wipe at a time for use. Reseal after use to prevent wipes from drying out 

  • USE:

    Disinfecting wipes for all-purpose cleaning and safely cleaning hands.

  • WARNINGS:

    • Flammable:keep away from open flame
    • For external use only

    Do not use

    • on or around the eyes
    • If irritation occurs, discontinue use

    Keep out of reach of children.

    • Contact medical help or poison control immediately, if swallowed
    • Do not use on children less than two months of age
  • Package Labeling:

    150 wipes

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79816-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79816-001-01150 in 1 DRUM03/01/2020
    13 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2020
    Labeler - Nano4you Performance Importacao E Distribuicao LTDA (944598183)
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