Blue Bear Antibacterial Hand Wipes

Manufacturer
Blue Bear Protection LLC | AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
Effective date
2020-12-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:34:47

Label at a glance#

ProductBlue Bear Antibacterial Hand Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

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)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Antibacterial / Antifungal, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15pcs15pcs

100 pis100 pis

500 pcs500 pcs

100 pcs canister100 pcs canister

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2375303benzalkonium chloride 0.23 % Medicated PadPSN5
2375303benzalkonium chloride 2.3 MG/ML Medicated PadSCD5
2375303benzalkonium chloride 0.23 % Medicated PadSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81005-001-01Blue Bear Antibacterial Hand Wipes0.0065835 g in 1 PATCHCLOTH0.00658355
81005-001-02Blue Bear Antibacterial Hand Wipes15 in 1 PACKAGECLOTH155
81005-001-03Blue Bear Antibacterial Hand Wipes0.010206 g in 1 PATCHCLOTH0.0102065
81005-001-04Blue Bear Antibacterial Hand Wipes100 in 1 PACKAGECLOTH1005
81005-001-05Blue Bear Antibacterial Hand Wipes0.0067 g in 1 PATCHCLOTH0.00675
81005-001-06Blue Bear Antibacterial Hand Wipes500 in 1 CANISTERCLOTH5005
81005-001-07Blue Bear Antibacterial Hand Wipes0.0067 g in 1 PATCHCLOTH0.00675
81005-001-08Blue Bear Antibacterial Hand Wipes100 in 1 CANISTERCLOTH1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81005-001BLUE BEAR ANTIBACTERIAL HAND WIPES (BENZALKONIUM CHLORIDE) CLOTH [BLUE BEAR PROTECTION LLC]5Legacy NDC, 8 package rows20201209_b0d94022-8485-0d1a-e053-2a95a90ae103.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b5f8b1de-0d37-2bc9-e053-2a95a90a2febb0d94022-8485-0d1a-e053-2a95a90ae1032020-12-08WarningsExact identifier
spl id: b5f8b1de-0d37-2bc9-e053-2a95a90a2feb
spl set id: b0d94022-8485-0d1a-e053-2a95a90ae103

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.