Forticept Wounds and Burns Hydrogel

Manufacturer
Lidan, inc. | Cosco International, Inc.
Effective date
2025-03-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:57:51

Label at a glance#

ProductForticept Wounds and Burns Hydrogel
Active ingredientBENZETHONIUM CHLORIDE, LIDOCAINE
Label structure15 sections

Indications and uses

For temporary relief of pain or discomfort for superficial and full thickness burns or wounds. Topical antiseptic to help decrease the risk of infections. Helps protect skin and supports healing of cuts, scrapes, burns, and wounds.

Dosage and administration

Adults and children 2 years of age and older: • Clean affected area from dirt and debris, let it dry. • Apply Forticept Analgesic Antiseptic Hydrogel and cover affected area with a clean gauze if needed. • Repeat this procedure 1-3 times daily or as needed until condition improves or medical assistance is rendered.

Storage and handling

Keep container closed when not in use. Store at room temperature, avoid freezing. Do not store below 32F/0 0 C or above 95F/35 0 C for extended periods of time.

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient/Purpose:

LIDOCAINE HCL (4.0%)..........................Topical Analgesic
BENZETHONIUM CHLORIDE (0.1%)....................Antiseptic

Uses:

OTC - Purpose Section

For temporary relief of pain or discomfort for superficial and full thickness burns or wounds. Topical antiseptic to help decrease the risk of infections. Helps protect skin and supports healing of cuts, scrapes, burns, and wounds.

INDICATIONS & USAGE SECTION

Topical analgesic - for temporary relief of pain or discomfort for superficial and full thickness burns or wounds.

Topical antiseptic - to help decrease the risk of wounf and skin infections.

WARNINGS:

WARNINGS SECTION

For external use only!

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 immidiately.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

Discontinue Use after 7 days unless directed by a doctor

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:
• Clean affected area from dirt and debris, let it dry.
• Apply Forticept Analgesic Antiseptic Hydrogel and cover affected area with a clean gauze if needed.
• Repeat this procedure 1-3 times daily or as needed until condition improves or medical assistance is rendered.

OTC - ASK DOCTOR SECTION

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

ALLANTOIN, ALPHA TOCOPHEROL, C13-14 ISOPARAFFIN, CETOSTEARYL ALCOHOL, CHLORPHENESIN, D-PANTHENOL, FD&C BLUE #1, GLYCERIN, HYDROLYZED COLLAGEN, LANOLIN, LAURETH-7, PARAFFINUM LIQUIDUM, PETROLATUM, POLYACRYLAMIDE, POLYHEXANIDE, SHEA BUTTER, STEARETH-2, STEARETH-21, THYMOL, WATER

Storage and handling:

SPL UNCLASSIFIED SECTION

  • Keep container closed when not in use.
  • Store at room temperature, avoid freezing.
  • Do not store below 32F/00C or above 95F/350C for extended periods of time.

For Questions:

OTC - QUESTIONS SECTION

Lidan, Inc.
30 Wall Street, 8th Floor
New York, NY 10005
www.forticept.com

Please call: +1 212 709-8133

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3oz label3oz label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4oz label4oz label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72127-0803-0Forticept Wounds and Burns Hydrogel0.114 kg in 1 TUBEGEL0.1145
72127-0803-1Forticept Wounds and Burns Hydrogel0.085 kg in 1 TUBEGEL0.0855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72127-0803FORTICEPT WOUNDS AND BURNS HYDROGEL (BENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) GEL [LIDAN, INC.]5Current NDC, Legacy NDC, 2 package rows20250327_c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72127-080372127-0803-0, 72127-0803-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML · Source PDF

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
Forticept Wounds and Burns HydrogelBENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDELidan, inc.c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f2025-03-25WarningsExact identifier
ndc (package): 72127-0803-1
ndc (package): 72127-0803-0
ndc (product): 72127-0803
ndc11 (package): 72127080301
ndc11 (package): 72127080300
spl id: 3b775197-f88c-4e50-a12d-c44925706e8b
spl set id: c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f

Reported adverse events (FAERS/openFDA)#

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