Forticept Antimicrobial Gel
FDA Label NDC 52261-0701

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosco International, Inc. for the product Forticept Antimicrobial Gel (NDC 52261-0701). 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 active ingredient/purpose, uses, warnings, indications & usage section, otc - stop use section, otc - keep out of reach of children, directions:, storage and handling:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient/purpose

→ Uses

→ Warnings

→ Indications & Usage Section

→ Otc - Stop Use Section

→ Otc - Keep Out Of Reach Of Children

→ directions:

→ storage And Handling:

→ inactive Ingredients:

→ 60g Plpldp

→ 90g plpldp

→ 120g plpldp

Active Ingredient/Purpose

Benzethonium Chloride............Antiseptic

Thymol................................Antiseptic

Uses

Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips. Topical antiseptic to help decrease the risk of skin infections.

Warnings

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

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

Directions:

Adults and children 2 years of age and older:

Clean affected area from dirt and debris, let it dry. Apply a thin layer of Forticept^TM Antimicrobial Gel and cover affected area with a clean bandage if needed. Repeat this procedure 1-3 times daily or as needed until condition improves.

Children under 2 years of age: please, consult a doctor

Storage And Handling:

Store at room temperature, avoid freezing

Inactive Ingredients:

Allantoin, Blue #1 dye, Cetearyl Alcohol, Chamomile (Matricaria recutita) Extract, Glycerin, Lanolin, Mineral oil, Petrolatum, Polyhexanide, Shea Butter, Simulgel EG, Steareth-2, Steareth-21, Water, Yarrow (Achillea millefolium) Extract