HAND SANITIZER- benzalkonium chloride aerosol, foam

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Personal Care Products, Shanghai LIfe Beauty Cosmetics Ltd, Ningbo Unichem Household Products Co Ltd, Ningbo Liyuan Daily Chemical Products Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Benzalkonium Chloride

PURPOSE

Purpose

Antimicrobial

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

WARNINGS

Warnings:

For external use only.

When using this product: Avoid contact with eyes. In case of eye contact, flush with plenty of water. Avoid contact with broken skin.

Stop use and ask a doctor if irritation develops.

DOSAGE & ADMINISTRATION

Directions:

Wet hands thoroughly with product and rub into skin until dry.

For children under 6, use only under adult supervision.

Not recommended for infants.

INACTIVE INGREDIENT

Inactive Ingredients
Water(Aqua), Benzalkoinum chloride, cetrimonium chloride, disodium cocoamphodicetate, fragrance, glycerin, citric acid, dimethicone, tetrasodium EDTA

INDICATIONS & USAGE

Use: To reduce bacteria on the skin.

PRINCIPAL DISPLAY PANEL

Personal Care

Alcohol Free

Foaming Hand Sanitizer

Superior protection

Kills 99.9% of germs*

Clean Fresh Scent

7 fl oz (207 ml)

INGREDIENTS AND APPEARANCE

HAND SANITIZER  
benzalkonium chloride aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-9088
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	.27 mL  in 207 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID (UNII: 2968PHW8QP)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-9088-7	207 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/05/2011

Labeler - Personal Care Products (966155082)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai LIfe Beauty Cosmetics Ltd		529125509	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Unichem Household Products Co Ltd		528196956	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Liyuan Daily Chemical Products Co Ltd		530766098	manufacture