VYTIS SHIELD ALOE VERA FOAM HAND SANITIZER- benzalkonium chloride spray

Vytis Shield Aloe Vera Foam Hand Sanitizer by

Drug Labeling and Warnings

Vytis Shield Aloe Vera Foam Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Vytis Shield, Llc. 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

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 develops and persists for more than 72 hours.

Keep out of reach of children.

Children should be supervised when using this product. Do not freeze.

Directions

Apply a small amount into palms of hands and spread on both hands. Rub into skin until dry.

Inactive Ingredients

1-Octadecanaminium NN dimethyl (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

Questions or comments

Call:1-888-489-2719

Mon. - Fri. 9:00 AM to 5:00 PM (EST)

Package Labeling:

INGREDIENTS AND APPEARANCE

VYTIS SHIELD ALOE VERA FOAM HAND SANITIZER 
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70299-001
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
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)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70299-001-00	1 in 1 BOX	12/03/2015
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 70299-001-01	1 in 1 BOX	12/03/2015
2		236 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 70299-001-02	1 in 1 BOX	12/03/2015
3		1000 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/03/2015

Labeler - Vytis Shield, Llc (039382748)