FDA Label for Blue Bear Antibacterial Hand Wipes
View Indications, Usage & Precautions
Blue Bear Antibacterial Hand Wipes Product Label
The following document was submitted to the FDA by the labeler of this product Blue Bear Protection Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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:
- Benzalkonium Chloride (0.23%, weight/weight (w/w)
- 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
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
Otc - 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.
Otc - Stop Use
Seek a doctor if redness, swelling, itching, or burning occurs on skin
Otc - 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
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