GFS BIOPROTECT ALCOHOL FREE HAND SANITIZER- benzalkonium chloride liquid
GFS-US

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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GFS Bioprotect Alcohol Free Hand Sanitizer

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-(Trimethoxysilyl) 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:

Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76426-020-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2016	12/31/2021
2	NDC:76426-020-21	210 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2016	12/31/2021
3	NDC:76426-020-90	900 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2016	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/28/2016	12/31/2021

Labeler - GFS-US (967789228)

Revised: 10/2021

Document Id: cdc551cf-977f-0f18-e053-2a95a90aeb0b

Set id: 762fa074-f5f4-4b4a-882e-930d137a4c25

Version: 6

Effective Time: 20211007

GFS-US