Label: BLUE BEAR ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 81005-001-01, 81005-001-02, 81005-001-03, 81005-001-04, view more81005-001-05, 81005-001-06, 81005-001-07, 81005-001-08 - Packager: Blue Bear Protection LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 8, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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:
- 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)
- Purpose
- Use
- Warnings
- Do not use
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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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
BLUE BEAR ANTIBACTERIAL HAND WIPES
benzalkonium chloride clothProduct 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)