Label: JUICEY ANTIBACTERIAL HAND 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 28, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    Benzalkonium Chloride %0.25 w/w. Purpose : Antibacterial

  • Purpose

    Antibacterial, Wet Wipes

  • Use

    Antibacterial wet wipes helps reduce bacteria (organisms).

    Effective on bacterias :

    Staphylococcus aureus ATCC 6538,

    Pseudomonas aeruginosa ATCC 15442,

    Enterococcus hirae ATCC 10541,

    Escherichia coli ATCC 10536

  • Warnings

    Keep away from children and direct sunlight. Children should not use this product without an adult supervision. For external use only. In case of poisoning, call the National Toxitation Information Center. Awoid contact with eyes.

  • Do not use

    Do not use with eyes. For external use only.

  • WHEN USING

    In case of inhaling: If you feel uncomfortable get some fresh ait. In case of skin Irritation: Occurs stop using the wipes immediately and wash the affected area with water and soap for at least 15 minutes. People with sensitive skin, pregnant women, breastfeeding women and children under the age of 12 should consult a doctor/pharmacist before using the product. Seek for medical advice if necessary. In case of contact with eyes: If you are wearing contact lenses, remove them immediately. Rince your eyes with plenty of clean water. In case of swallowing: Call your local Toxication Center and get medical help. There is no specific antidote therefore treatment must be done according to symptoms. Treatment: Treatment is indicated according to the indication. CALL YOUR LOCAL POISON CENTER.

  • STOP USE

    Treatment is indicated according to the indication. CALL YOUR LOCAL POISON CENTER

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children should not use this product without an adult supervision.

  • Directions

    Provides practical cleaning without need of water and soap. Used for hand cleaning. Open the adhesive label and pick up a wipe. Gently wipe your hands with antibacterial wipe. No rinsing required. User group : General public

  • Other Information

    Store in a cool and dry place.

  • Inactive Ingredients

    Aqua, Parfum, C12-15 Pareth-12, Glycerin, Polysorbate 20, Propylene Glycol, Tetrasodium EDTA, Piroctone Olamine, Tocopheryl Acetate, Panthenol, Citric Acid, Aloe Barbadensis Leaf Extract

  • Package Label - Principal Display Panel

    60 Pcs. Antibacterial Wipes. NDC : 76964-901

  • INGREDIENTS AND APPEARANCE
    JUICEY ANTIBACTERIAL HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76964-901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.001 g  in 100 g
    C12-15 PARETH-12 (UNII: 131316X18L) 0.35 g  in 100 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.2 g  in 100 g
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.2 g  in 100 g
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB) 0.1 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.25 g  in 100 g
    EDETATE SODIUM (UNII: MP1J8420LU) 0.1 g  in 100 g
    PANTHENOL (UNII: WV9CM0O67Z) 0.001 g  in 100 g
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.001 g  in 100 g
    WATER (UNII: 059QF0KO0R) 98.66 g  in 100 g
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.008 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76964-901-0160 in 1 PACKAGE10/28/2020
    15 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/28/2020
    Labeler - TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI (535142780)
    Registrant - TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI (535142780)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI535142780manufacture(76964-901)