BLUE BEAR ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth

Blue Bear Antibacterial Hand Wipes by

Drug Labeling and Warnings

Blue Bear Antibacterial Hand Wipes by is a Otc medication manufactured, distributed, or labeled by Blue Bear Protection LLC, AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BLUE BEAR ANTIBACTERIAL HAND WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81005-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.23 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81005-001-02	15 in 1 PACKAGE	10/01/2020
1	NDC: 81005-001-01	0.0065835 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 81005-001-04	100 in 1 PACKAGE	10/01/2020
2	NDC: 81005-001-03	0.010206 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 81005-001-08	100 in 1 CANISTER	10/01/2020
3	NDC: 81005-001-07	0.0067 g in 1 PATCH; Type 0: Not a Combination Product
4	NDC: 81005-001-06	500 in 1 CANISTER	10/01/2020
4	NDC: 81005-001-05	0.0067 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Blue Bear Protection LLC (131113913)

Registrant - Blue Bear Protection LLC (131113913)

Establishment
Name	Address	ID/FEI	Business Operations
AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI		365577706	manufacture(81005-001)