BioProtect Alcohol Free Hand Sanitizer

BioProtect Alcohol Free Hand Sanitizer by

Drug Labeling and Warnings

BioProtect Alcohol Free Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Global BioProtect, LLC, Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOPROTECT ALCOHOL FREE HAND SANITIZER- benzalkonium chloride aerosol, foam 
Global BioProtect, 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.

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BioProtect Alcohol Free Hand Sanitizer

Drug Facts

Active Ingredient:

Benzalkonium Chloride 0.13%

Purpose:

Antiseptic Hand Sanitizer

Uses:

Hand Sanitizer to help derease bacteria on the skin - Recommended for repeated use.

Warnings:

Do not freeze.

For external use only.

Do not use in ears or mouth.

When using this product,

avoid contact with the eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor

if redness or irritaton develop and persist for more than 72 hours.

Keep out of reach of children.

Children should be supervised when using this product.

Directions:

Apply a small amount into palms and spread on both hands. Rub into skin until dry.

Inactive Ingredients:

Water, Polyaminopropyl biguanide, 1-Octadecanaminum NN dimethyl(3-trime-thoxysilyl) propyl chloride, C12-15 Pareth 12, Caprylyl Glucoside, Sodium Benzoate, Aloe Barbadensis Leaf Juice Extract, Cironellol, Citric Acid, FD&A Blue No.1

Package Labling: 1890ml

Package Labeling: 1890ml (Tilt & Pour)

Package Labeling : 1000L

BIOPROTECT ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79141-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 0.001 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
C12-15 PARETH-12 (UNII: 131316X18L)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79141-000-01	1.89 L in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2020	12/31/2021
2	NDC: 79141-000-02	1.89 L in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2020	12/31/2021
3	NDC: 79141-000-03	1000 L in 1 TANK; Type 0: Not a Combination Product	05/30/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/30/2020	12/31/2021

Labeler - Global BioProtect, LLC (080387141)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		926433855	manufacture(79141-000)

Revised: 10/2021

Document Id: cdc4c165-7315-951e-e053-2995a90a7f89

34390-5

Set id: 4807a276-aea3-4de8-ac49-9a9fc7f7b7bb

Version: 2

Effective Time: 20211007