Label: BLUE BEAR 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 December 8, 2020

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  • SPL UNCLASSIFIED SECTION

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Benzalkonium Chloride (0.23%, weight/weight (w/w)
    2. Aqua,
    3. Benzoic Acid,
    4. Citral,
    5. Dehydroacetic Acid,
    6. Dicaprylyl Carbonate,
    7. Glycerin,
    8. Glyceryl Oleate,
    9. Lauryl Glucoside,
    10. Limonene,
    11. Linalool
    12. Olus Oil,
    13. Parfum,
    14. Phenoxyethanol,
    15. Polyglyceryl-2 Dipolyhydroxystearate,
    16. Polysorbate 20,
    17. Propylene Glycol,
    18. Tetrasodium EDTA
  • Active Ingredient(s)

    Benzalkonium Chloride 0.23% w/w. Purpose: Antibacterial/ Antifungal

  • Purpose

    Antibacterial / Antifungal, Hand Sanitizer

  • Use

    Antibacterial Wet Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    Keep out of reach of children. For external use only.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    Do not eat or drink while using the product. Follow all the instructions to avoid risks on human and environmental health. In case of contact with eyes:If you are wearing contact lenses,remove them immediately.Rinse your eyes with plenty of clean water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Seek a doctor if redness, swelling, itching, or burning occurs on skin

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Provides practical cleaning without the need of water and soap. It is used for hand cleaning. Open the label and pick up a wipe. Gently wipe your hands with antibacterial wipe. No rising required
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store the product dry, cool, clean place and keep away from direct sunlight
  • Inactive ingredients

    Aqua, Benzoic Acid, Citral, Dehydroacetic Acid, Dicaprylyl Carbonate, Glycerin, Glyceryl Oleate, Lauryl Glucoside, Limonene, Linalool Olus Oil, Parfum, Phenoxyethanol, Polyglyceryl-2 Dipolyhydroxystearate, Polysorbate 20, Propylene Glycol, Tetrasodium EDTA

  • Package Label - Principal Display Panel

    15pcs

    100 pis

    500 pcs

    100 pcs canister

  • INGREDIENTS AND APPEARANCE
    BLUE BEAR ANTIBACTERIAL HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81005-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.23 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    WATER (UNII: 059QF0KO0R)  
    CITRAL (UNII: T7EU0O9VPP)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    FATTY-ACID AMIDE HYDROLASE 1 (UNII: E747F394ZQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81005-001-0215 in 1 PACKAGE10/01/2020
    1NDC:81005-001-010.0065835 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:81005-001-04100 in 1 PACKAGE10/01/2020
    2NDC:81005-001-030.010206 g in 1 PATCH; Type 0: Not a Combination Product
    3NDC:81005-001-08100 in 1 CANISTER10/01/2020
    3NDC:81005-001-070.0067 g in 1 PATCH; Type 0: Not a Combination Product
    4NDC:81005-001-06500 in 1 CANISTER10/01/2020
    4NDC:81005-001-050.0067 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Blue Bear Protection LLC (131113913)
    Registrant - Blue Bear Protection LLC (131113913)
    Establishment
    NameAddressID/FEIBusiness Operations
    AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI365577706manufacture(81005-001)
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