Label: JUICEY ANTIBACTERIAL WIPES- benzalkonium chloride 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 October 27, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13% v/v - antiseptic

  • Inactive Ingredients

    Aqua, Parfum, C12-15 Pareth-12, Glycerin, Polysorbate 20, Propylene Glycol, Tetrasodium EDTA, Piroctone Olamine, Tocopheryl Acetate (Vitamin E), Panthenol, Citric Acid, Aloebarbadensis Leaf Extract

  • Purpose

    Antiseptic- antibacterial hand towelettes

  • Use

    Wipes used on hands to reduce bacteria on the skin

  • Warnings

    Product contains flammable liquid. Keep away from flame and direct sunlight. Children should not use this product without adult supervision. For external use only. If ingested, call the National Toxication Information Center or seek medical attention. Keep away from eyes.

  • Do Not Use

    Do not use if allergic to any of its ingredients. Do not use near eyes. Do not use on children under 2 months of age. Consult a doctor before use if pregnant, breast feeding, have sensitive skin, or are under the age of 12. Do not buy if packaging was opened and/or damaged.

  • When Using

    In case of eye contact, remove any contact lenses and flush eyes repeatedly with water. In case of swallowing, contact a poison control center or seek medical attention.

  • KEEP OUT OF REACH OF CHILDREN

    Store out of reach of children. Children under the age of 12 should be supervised during use.

  • Directions

    Open the hard plastic snap cover to reveal the adhesive label that reads "OPEN". Peel back the adhesive label and remove one wipe at a time. Wipe your hands with the antibacterial wipe until all of the solution is absorbed. Seal the packaging tightly when done.

  • Storage

    Store in a cool, dry place. Store out of reach of children. Do not store near food, drinks, or animal feed. Store away from direct sunlight and open flame.

  • Package Label

    Principal Display Panel60 Count Antibacterial Wipes Pouch NDC: 80783-901-60

  • INGREDIENTS AND APPEARANCE
    JUICEY ANTIBACTERIAL WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80783-901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.007 g  in 5.33 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    C12-15 PARETH-12 (UNII: 131316X18L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80783-901-6060 in 1 POUCH10/27/2020
    15.33 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/27/2020
    Labeler - MEHMET YILDIZ YILDIZ KOZMETIK (533149270)
    Registrant - MEHMET YILDIZ YILDIZ KOZMETIK (533149270)