FORTICEPT ANTIMICROBIAL WOUND CLEANSER- benzalkonium chloride liquid 
Cosco International, 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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Drug Facts

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  For external use only.

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 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.  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:

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

60 mL PLPLDP

118 mL PLPLDP

118 mL PLPLDP

240 mL PLPLDP

240 mL PLPLDP

473 ml PLPLDP

473 ml PLPLDP

FORTICEPT ANTIMICROBIAL WOUND CLEANSER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-0700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) benzalkonium chloride1.3 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52261-0700-060 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/27/2016
2NDC:52261-0700-1118 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/27/2016
3NDC:52261-0700-2240 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/27/2016
4NDC:52261-0700-3473 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/27/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/27/2016
Labeler - Cosco International, Inc. (016433141)
Registrant - Cosco International, Inc. (016433141)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture(52261-0700) , label(52261-0700) , pack(52261-0700)

Revised: 10/2016
Document Id: bed9313c-d763-4c02-8b00-92cd66bd393d
Set id: c8ed8510-b439-45f5-9bb7-952016aeac2c
Version: 2
Effective Time: 20161027
 
Cosco International, Inc.