BIOPROTECT ALCOHOL FREE HAND SANITIZER- benzalkonium chloride spray

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, Vin Mar Industries LLC, BRENNTAG MID-SOUTH, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient:

Benzalkonium Chloride 0.13%

Purpose:

Antiseptic Hand Sanitizer

Uses:

Hand Sanitizer to help decrease 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 irritation 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-trimethoxysilyl) propyl chloride, C12-15 Pareth 12, Caprylyl Glucoside, Benzalkonium Chloride 50%, Sodium Benzoate, Glycerin, Aloe Barbadensis Leaf Juice Extract, Citronellol, Citric Acid, FD&C Blue No. 1

Package Labeling:

INGREDIENTS AND APPEARANCE

BIOPROTECT ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79141-001
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 1 mL

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)
GLYCERIN (UNII: PDC6A3C0OX)
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: 79141-001-00	236 mL in 1 CAN; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020

Labeler - Global BioProtect, LLC (080387141)

Establishment
Name	Address	ID/FEI	Business Operations
Vin Mar Industries LLC		114772616	pack(79141-001)

Establishment
Name	Address	ID/FEI	Business Operations
BRENNTAG MID-SOUTH, INC.		122625064	manufacture(79141-001)