Forticept Wounds And Burns Hydrogel
FDA Label NDC 72127-0803

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lidan, Inc. for the product Forticept Wounds And Burns Hydrogel (NDC 72127-0803). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, uses:, indications & usage, warnings:, otc - keep out of reach of children, otc - when using, otc - do not use, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient/Purpose:

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

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.

Indications & Usage

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:

For external use only!

Otc - Keep Out Of Reach Of Children

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

Otc - When Using

When using this product avoid contact with eyes.

Otc - Do Not Use

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

Otc - Stop Use

Discontinue Use after 7 days unless directed by a doctor

Directions:

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

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

Inactive Ingredients:

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:

  • 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:

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

Please call: +1 212 709-8133

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