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

15pcs
(click image for full-size original)
100pcs
(click image for full-size original)

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)
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: 10/2020 Blue Bear Protection LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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