OTC Medication Information: Blue Bear Antibacterial Hand Wipes

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.

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

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

• 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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.23 g in 100 g

Inactive Ingredients Ingredient Name Strength GLYCERIN BENZOIC ACID WATER CITRAL DEHYDROACETIC ACID GLYCERYL OLEATE LINALOOL, (+)- PROPYLENE GLYCOL ETIDRONATE TETRASODIUM DICAPRYLYL CARBONATE LAURYL GLUCOSIDE LIMONENE, (+)- FATTY-ACID AMIDE HYDROLASE 1 PHENOXYETHANOL POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE POLYSORBATE 20

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:81005-001-02 15 PATCH in 1 PACKAGE contains a PATCH (81005-001-01) 1 NDC:81005-001-01 0.0065835 g in 1 PATCH This package is contained within the PACKAGE (81005-001-02) 2 NDC:81005-001-04 100 PATCH in 1 PACKAGE contains a PATCH (81005-001-03) 2 NDC:81005-001-03 0.010206 g in 1 PATCH This package is contained within the PACKAGE (81005-001-04) 3 NDC:81005-001-08 100 PATCH in 1 CANISTER contains a PATCH (81005-001-07) 3 NDC:81005-001-07 0.0067 g in 1 PATCH This package is contained within the CANISTER (81005-001-08) 4 NDC:81005-001-06 500 PATCH in 1 CANISTER contains a PATCH (81005-001-05) 4 NDC:81005-001-05 0.0067 g in 1 PATCH This package is contained within the CANISTER (81005-001-06)

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	Operations
AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI		365577706	manufacture (81005-001)

Revised: 12/2020 Blue Bear Protection LLC