X3 Hand Sanitizer (Spray)

X3 CLEAN - hand sanitizer spray spray
X3 Labs 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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Purpose Antimicrobial

Use To decrease bacteria on the skin that could cause disease.

Warnings For external use only. Do not freeze.

Do not use in or near eyes. In case of contact with eyes, flush thoroughly with water.

Stop use and ask doctor if skin irritation develops.

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

Directions Apply a small amount to palms and rub hands thoroughly until completely dry.

Purified Water, Glycerin, Cocamidopropyl Bentaine.

X3 CLEAN
hand sanitizer spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:26550-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	1.3 uL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:26550-001-10	8 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333	09/01/2009

Labeler - X3 Labs Inc. (243700361)

Name	Address	ID/FEI	Business Operations
Establishment
Canadian Custom Packaging Company		207062514	manufacture