OPTISOURCE ANTIBACTERIAL FOAM HAND- benzalkonium chloride soap
Charlotte Products 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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Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

For hand washing to decrease bacteria on the skin
Recommended for repeated use

Warnings

For external use only

When using

this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop using and ask doctor if

irritation or redness develops, or if 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

Pump a small amount of foam into palm of hand
Rub thoroughly over all surfaces of both hands for 15 seconds
Rinse with potable water

Inactive Ingredients Water/Agua/Eau, Coco-glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric acid

12504 Label

OPTISOURCE ANTIBACTERIAL FOAM HAND
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64646-001
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 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
COCO GLUCOSIDE (UNII: ICS790225B)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64646-001-02	4 in 1 CASE	12/22/2015
1		1250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/03/2015

Labeler - Charlotte Products Ltd. (248293359)

Registrant - Charlotte Products Ltd. (248293359)

Name	Address	ID/FEI	Business Operations
Establishment
Charlotte Products Ltd.		248293359	manufacture(64646-001)