Label: JUICEY 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 September 11, 2020

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  • Active Ingredient

    Ethyl Alcohol (Ethanol) 70% v/v - Antiseptic

  • Inactive Ingredients

    peg-7 glyceryl cocoate, edetic acid, anhydrous citric acid, polysorbate 20, cocamidopropyl betaine, distilled lemon oil, glycerin, water, aloe barbadensis leaf extract, tocopheryl acetate (vitamin E)

  • Purpose

    Antiseptic- antibacterial hand towelettes

  • Use

    Wipes used on hands to reduce bacteria on the skin

  • Warnings

    Highly flamable liquid. 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 redness or irritation occurs and persists for longer than 48 hours, seek medical attention.

  • Do not use

    Do not use if allergic to any of its ingredients. Do not use on children under 2 months of age. Do not use while eating, drinking, or smoking. Do not use near eyes or open wounds.

  • When using

    If ingested, contact a poison control center immediately. If eye contact occurs, remove any contact lenses and flush eyes with water repeatedly.

  • Stop use

    Stop use if redness or irritation occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Store in places out of reach of children. Supervise use by children under the age of 6. If swallowed, contact a poison control center or seek medical attention immediately.

  • Directions

    Open hard plastic flip cover and remove one towelette at a time and then securely close the packaging. Wipe towelette on the desired area of the body and allow to dry. Do not flush towelettes.

  • Storage

    Keep away from flame and direct sunlight. Store in a cool, dry placeout of reach of children. Do not store near food, drinks, or animal feed. Store tightly in its original packaging.

  • Package Label

    40 Count Alcohol Wipes Canister NDC: 78141-903-40

    80 Count Alcohol Wipes Canister NDC: 78141-903-80

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    JUICEY ALCOHOL HAND WIPES 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78141-903
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LEMON OIL, DISTILLED (UNII: ET5GD00TRP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78141-903-4040 in 1 CANISTER09/16/2020
    14.37 mL in 1 POUCH; Type 0: Not a Combination Product
    2NDC:78141-903-8080 in 1 CANISTER09/16/2020
    24.37 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/16/2020
    Labeler - Fuson LLC (113376279)
    Registrant - MEHMET YILDIZ YILDIZ KOZMETIK (533149270)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEHMET YILDIZ YILDIZ KOZMETIK533149270manufacture(78141-903) , label(78141-903)
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