BIOARMOR ALCOHOL FREE HAND SANITIZER- benzalkonium chloride liquid

BioArmor Alcohol Free Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Benzalkonium chloride 0.13% ​

Purpose

Antiseptic Hand Sanitizer   

Uses

• Hand Sanitizer to help decrease bacteria on skin.
• Recommended for repeated use.

Warnings

For external use only.

• Do not use in ears or mouth.

When using this product

• Avoid contact with eyes.
• in case of contact flush eyes with water.

Stop use and ask 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 of hands and spread on both hands. Rub into skin until dry.

Inactive Ingredients

1-Octadecanaminium-N,N-dimethyl-N-{3-(trimethoxysilyl)propyl} chloride, Aloe Barbadenis leaf extract, C12-C15 Pareth 12, Caprylyl Glucoside, Citric Acid Monohydrate, Citronellol, FD&C Blue 1, Glycerin, Polyaminopropyl biguanide, Sodium benzoate, Water.

Bioarmor Alcohol-free Hand Sanitizer-50mL

Bioarmor Alcohol-free Hand Sanitizer-210mL

INGREDIENTS AND APPEARANCE

BIOARMOR ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70953-001
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
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
C12-15 PARETH-12 (UNII: 131316X18L)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70953-001-00	210 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2016
2	NDC: 70953-001-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/06/2016

Labeler - BioArmor, LLC (079341809)

Registrant - BioArmor, LLC (079341809)