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Name:X3 Clean
Manufacturer:X3 Labs Inc.
Category:Over-the-counter (OTC) Marketed Drugs


X3 Hand Sanitizer (Foam)

X3 CLEAN  - benzalkonium chloride aerosol, foam 
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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X3 Hand Sanitizer (Foam)

Active Ingredient
Benzalkonium Chloride 0.13%

Purpose  
Antimicrobial

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

Warnings
For external use only.

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.

Other Information   Do not freeze.

Inactive Ingredients
Purified Water, Glycerin, Cocamidopropyl Betaine.

Questions? www.x3clean.com

2.5 oz Hand Sanitizer Foam

8.5 oz Hand Sanitizer Foam

1L Bottle Hand Sanitizer Foam

1L Cartridge Hand Sanitizer Foam

4L Refill Hand Sanitizer Foam


X3 CLEAN 
hand sanitizer foam aerosol, foam
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:26550-001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzalkonium Chloride (Benzalkonium ) Benzalkonium Chloride 1.3 uL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Glycerin  
Cocamidopropyl Betaine  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:26550-001-12 75 mL in 1 BOTTLE None
2 NDC:26550-001-14 250 mL in 1 BOTTLE None
3 NDC:26550-001-16 1000 mL in 1 BOTTLE None
4 NDC:26550-001-18 1000 mL in 1 CARTRIDGE None
5 NDC:26550-001-20 4000 mL in 1 BOTTLE None

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

Labeler - X3 Labs Inc. (243700361)
Establishment
Name Address ID/FEI Operations
Canadian Custom Packaging Company 207062514 manufacture

Revised: 08/2009 X3 Labs Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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