ANTISEPTIC HAND SANITIZER FOAM- benzalkonium chloride solution
DaLian Jaesve Cleaning Product Co., Ltd

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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Antiseptic Hand Sanitizer Foam

Drug Facts

Active ingredient

Benzalkonium chloride 0.1%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only

Do not use

in the eyes

Stop use and ask a doctor if:

Irritation and redness develop
Condition persists 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 allow to dry without wiping

Other Information

store at room temperature

Inactive ingredients

Water, dodecylbetaine, lauramine oxide

Package Labeling:

Bottle

ANTISEPTIC HAND SANITIZER FOAM
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77624-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
LAURYL BETAINE (UNII: Y4P927Q133)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77624-000-00	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/20/2020

Labeler - DaLian Jaesve Cleaning Product Co., Ltd (527127803)