Label: ALCOHOL HAND WIPES- ethyl 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 21, 2020

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  • Active Ingredient

    Ethyl Alcohol (Ethanol) 70%

  • Inactive Ingredients

    Aqua, glycerin, peg-7 glyceryl cocoate, polysorbate 20, cocamidopropyl betaine, dexpanthenol, citrus limon peel, citric acid, EDTA

  • Purpose

    Antiseptic- Antibacterial hand towelettes

  • Use

    Wipes used on hands and skin to reduce bacteria

  • Warnings

    For external use only, do not ingest. Do not use near eyes. Keep away from flame and direct sunlight. Do not eat, drink, or smoke during use. If irritation or redness occurs and persists for longer than 72 hours, consult a medical professional.

  • Do Not Use

    Do not use near eyes. Do not ingest. Do not eat, smoke, or drink during use. Do not use on or in open skin wounds. Do not use on children under 2 months of age.

  • When Using

    If ingested, contact a poison control center immediately. If eye contact occurs, flush eyes with water repeatidly.

  • Stop Use

    Stop use if redness, irritation, or rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Store in places out of reach of children. Supervise use by children under the age of 6.

  • Dierctions

    Peel back open label slowly. Pull out one wipe at a time and re-seal the packaging tightly. Wet hands thoroughly with product and allow to dry without wiping.

  • Storage

    Keep away from direct sunlight. Store tightly closed in its original packaging and in a cool, dry place. Keep away from food, drinks, and animal feed. Store away from reach of children.

  • Package Label

    120 Count Canister: 78141-211-12

    200 Count Canister: 78141-211-20

    500 Count Canister: 78141-211-50

    78141-211-20

  • INGREDIENTS AND APPEARANCE
    ALCOHOL HAND WIPES 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78141-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3.059 mL  in 4.37 mL
    Inactive Ingredients
    Ingredient NameStrength
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LEMON OIL, DISTILLED (UNII: ET5GD00TRP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78141-211-502185 mL in 1 CANISTER; Type 0: Not a Combination Product09/16/2020
    2NDC:78141-211-20874 mL in 1 CANISTER; Type 0: Not a Combination Product09/16/2020
    3NDC:78141-211-12524.4 mL in 1 CANISTER; Type 0: Not a Combination Product09/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/16/2020
    Labeler - Fuson LLC (113376279)
    Registrant - OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI (595865355)
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