OTC Medication Information: GFS Bioprotect Alcohol Free Hand Sanitizer

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.

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
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE
ALOE VERA LEAF
WATER
C12-15 PARETH-12
CAPRYLYL GLUCOSIDE
CITRIC ACID MONOHYDRATE
.BETA.-CITRONELLOL, (R)-
FD&C BLUE NO. 1
GLYCERIN
POLYAMINOPROPYL BIGUANIDE
SODIUM BENZOATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76426-020-50 50 mL in 1 BOTTLE None
2 NDC:76426-020-21 210 mL in 1 BOTTLE None
3 NDC:76426-020-90 900 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 06/28/2016 12/31/2021
Labeler — GFS-US (967789228)

Revised: 10/2021 GFS-US

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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