GFS BIOPROTECT ALCOHOL FREE HAND SANITIZER- benzalkonium chloride liquid

GFS Bioprotect Alcohol Free Hand Sanitizer by

Drug Labeling and Warnings

GFS Bioprotect Alcohol Free Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by GFS-US. 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:

1-Octadecanaminium, N,N-Dimethyl (3-(Trihydroxysilyl)Propyl) Chloride, Aloe Barbadenis Leaf Extract, Aqua, C12-C15 Pareth-12, Caprylyl Glucoside, Citric Acid, Citronellol, FD&C Blue 1, Glycerin, Polyaminopropyl biguanide, Sodium benzoate

Questions:

1-336-434-3242 Mon-Fri 9:00AM-5:00PM (EST)

Package Lableing:

INGREDIENTS AND APPEARANCE

GFS BIOPROTECT ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76426-020
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
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
C12-15 PARETH-12 (UNII: 131316X18L)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76426-020-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2016
2	NDC: 76426-020-21	210 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2016
3	NDC: 76426-020-90	900 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/28/2016

Labeler - GFS-US (967789228)