ASSURED FOAMING HAND SANITIZER- benzalkonium chloride liquid
Greenbrier International Inc

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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Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

■ for washing hands to decrease bacteria on the skin ■ recommended for repeated use.

Warnings

For external use only

When using this product

avoid contact with the eyes. If contact occurs, flush eyes with water.

Stop use and ask a doctor if

irritation or rash develops and continues for more than 72 hours

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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 ■ no rinsing required.

Inactive ingredients

water, cetrimonium chloride, disodium cocoamphodiacetate, dimethicone copolyol, fragrance, tocopherol acetate

Package Label

image description

ASSURED FOAMING HAND SANITIZER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:33992-0315
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:33992-0315-7	221 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/01/2015

Labeler - Greenbrier International Inc (610322518)