FORTICEPT ANTIMICROBIAL WOUND CLEANSER- benzalkonium chloride liquid

Forticept Antimicrobial Wound Cleanser by

Drug Labeling and Warnings

Forticept Antimicrobial Wound Cleanser by is a Otc medication manufactured, distributed, or labeled by Cosco International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient/Purpose

Benzakonium Chloride............Antiseptic

Uses

Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, includ-ing pressure sores, diabetic ulcers, cracked skin and lips. Topical antiseptic to help decrease the risk of skin infections.

WARNINGS

Warnings  For external use only.

INDICATIONS & USAGE

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes.

STOP USE

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

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

Directions:

Wound cleansing for adults and children 2 years of age and older:

Spray the affected area to clean dirt and debris, use a small amount of the product and wipe it off with a sterile gauze.

For use as First Aid antiseptic for adults and children 2 years of age and older:

• Clean the affected area
• Spray a small amount of this product on the area 1 to 3 times daily or as needed
• Wipe off excess with sterile gauze
• Cover affected area with a sterile bandage if needed
• When bandaged, let dry first

For children under 2 years of age: please, consult a doctor

Storage and handling:

Store at room temperature.

Inactive ingredients:

chamomile, (matricaria recutita) extract, cocamide MEA, cocamidopropyl betaine, disodium cocamphodiacetate, polyhexanide, water, yarrow (achillea millefolium) extract

60 mL PLPLDP

118 mL PLPLDP

240 mL PLPLDP

473 ml PLPLDP

INGREDIENTS AND APPEARANCE

FORTICEPT ANTIMICROBIAL WOUND CLEANSER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52261-0700
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 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
chamomile (UNII: FGL3685T2X)	.1 g  in 1000 g
COCO MONOETHANOLAMIDE (UNII: C80684146D)	.5 g  in 1000 g
cocamidopropyl betaine (UNII: 5OCF3O11KX)	4 g  in 1000 g
disodium cocoamphodiacetate (UNII: 18L9G3U51M)	1 g  in 1000 g
POLIHEXANIDE (UNII: 322U039GMF)	4 g  in 1000 g
water (UNII: 059QF0KO0R)	989.00 g  in 1000 g
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)	.1 g  in 1000 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52261-0700-0	60 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/27/2016
2	NDC: 52261-0700-1	118 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/27/2016
3	NDC: 52261-0700-2	240 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/27/2016
4	NDC: 52261-0700-3	473 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/27/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/27/2016

Labeler - Cosco International, Inc. (016433141)

Registrant - Cosco International, Inc. (016433141)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(52261-0700) , label(52261-0700) , pack(52261-0700)