Forticept Antimicrobial Wound Cleanser (Benzalkonium Chloride) Liquid [Cosco International, Inc.] -

FORTICEPT ANTIMICROBIAL WOUND CLEANSER (BENZALKONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.]
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NDC	52261-0700-0, 52261-0700-1, 52261-0700-2, 52261-0700-3
Set ID	c8ed8510-b439-45f5-9bb7-952016aeac2c
Category	HUMAN OTC DRUG LABEL
Packager	Cosco International, Inc.
Generic Name
Product Class
Product Number
Application Number	PART333A

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
benzalkonium chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	benzalkonium chloride	1.3 g in 1000 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/27/2016

Labeler - Cosco International, Inc. (016433141)

Registrant - Cosco International, Inc. (016433141)

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

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Medic

FORTICEPT ANTIMICROBIAL WOUND CLEANSER (BENZALKONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.]

Uses

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