BLUE BEAR ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth 
Blue Bear Protection LLC

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.

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Blue Bear Antibacterial Hand Wipes

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

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.

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

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

Directions

Other information

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

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)

Revised: 12/2020
Document Id: b5f8b1de-0d37-2bc9-e053-2a95a90a2feb
Set id: b0d94022-8485-0d1a-e053-2a95a90ae103
Version: 5
Effective Time: 20201208
 
Blue Bear Protection LLC