OPTISOURCE ANTIBACTERIAL FOAM HAND- benzalkonium chloride soap

OPTISOURCE Antibacterial Foam Hand by

Drug Labeling and Warnings

OPTISOURCE Antibacterial Foam Hand by is a Otc medication manufactured, distributed, or labeled by Charlotte Products Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OPTISOURCE ANTIBACTERIAL FOAM HAND 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64646-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/03/2015

Labeler - Charlotte Products Ltd. (248293359)

Registrant - Charlotte Products Ltd. (248293359)

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