Label: FORTICEPT ANTIMICROBIAL WOUND CLEANSER- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 52261-0700-0, 52261-0700-1, 52261-0700-2, 52261-0700-3 - Packager: Cosco International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 27, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient/Purpose
- WARNINGS
- INDICATIONS & USAGE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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:
- Inactive ingredients:
- 60 mL PLPLDP
- 118 mL PLPLDP
- 240 mL PLPLDP
- 473 ml PLPLDP
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INGREDIENTS AND APPEARANCE
FORTICEPT ANTIMICROBIAL WOUND CLEANSER
benzalkonium chloride liquidProduct 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)
