FDA.reportPublic FDA data

Forticept Antimicrobial Wound Cleanser

Manufacturer
Cosco International, Inc.
Effective date
2016-10-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:47:48

Label at a glance#

ProductForticept Antimicrobial Wound Cleanser
Active ingredientbenzalkonium chloride
Label structure12 sections

Dosage and administration

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 a...

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

Active Ingredient/Purpose

OTC - ACTIVE INGREDIENT SECTION

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

Uses

OTC - Purpose Section

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 SECTION

Warnings  For external use only.

Indications & Usage Section

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

When using this product avoid contact with eyes.

OTC - Stop Use Section

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

STORAGE AND HANDLING SECTION

Store at room temperature.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

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

60 mL PLPLDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL PLPLDP60 mL PLPLDP

118 mL PLPLDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118 mL PLPLDP118 mL PLPLDP

240 mL PLPLDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

240 mL PLPLDP240 mL PLPLDP

473 ml PLPLDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473 ml PLPLDP473 ml PLPLDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN2
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD2
1049254benzalkonium chloride 0.13 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52261-0700-02021-01-29C16284748780-1ba0f9c33-409b-a910-e053-dadaa90a0b85Drug Facts
52261-0700-12021-01-29C16284748780-1ba0f9c33-409b-a910-e053-dadaa90a0b85Drug Facts
52261-0700-22021-01-29C16284748780-1ba0f9c33-409b-a910-e053-dadaa90a0b85Drug Facts
52261-0700-32021-01-29C16284748780-1ba0f9c33-409b-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-0700-0Forticept Antimicrobial Wound Cleanser60 g in 1 BOTTLE, SPRAYLIQUID602
52261-0700-1Forticept Antimicrobial Wound Cleanser118 g in 1 BOTTLE, SPRAYLIQUID1182
52261-0700-2Forticept Antimicrobial Wound Cleanser240 g in 1 BOTTLE, SPRAYLIQUID2402
52261-0700-3Forticept Antimicrobial Wound Cleanser473 g in 1 BOTTLE, SPRAYLIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-0700FORTICEPT ANTIMICROBIAL WOUND CLEANSER (BENZALKONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.]2Legacy NDC, 4 package rows20161028_c8ed8510-b439-45f5-9bb7-952016aeac2c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52261-070052261-0700-0, 52261-0700-1, 52261-0700-2, 52261-0700-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
benzalkonium chlorideF5UM2KM3W7ACTIB
chamomileFGL3685T2XIACT
COCO MONOETHANOLAMIDEC80684146DIACT
cocamidopropyl betaine5OCF3O11KXIACT
disodium cocoamphodiacetate18L9G3U51MIACT
POLIHEXANIDE322U039GMFIACT
water059QF0KO0RIACT
ACHILLEA MILLEFOLIUM2FXJ6SW4PKIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bed9313c-d763-4c02-8b00-92cd66bd393dc8ed8510-b439-45f5-9bb7-952016aeac2c2016-10-27WarningsExact identifier
spl id: bed9313c-d763-4c02-8b00-92cd66bd393d
spl set id: c8ed8510-b439-45f5-9bb7-952016aeac2c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.