Tridergel
FDA Label NDC 73352-520

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trifluent Pharma Llc for the product Tridergel (NDC 73352-520). 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 other, active ingredients, purpose, indications & usage, warnings, otc - when using, otc - do not use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Benzalkonium Chloride (0.1%)

Purpose

Antimicrobial

Indications & Usage

Indications for management of:

  • Stage 1-2 open wounds
  • Superficial stasis ulcers
  • Superficial diabetic skin ulcers
  • Post-surgical incisions
  • First and second-degree burns
  • Cuts
  • Abrasions and skin irritations

Warnings

For external use only.

Otc - When Using

When using this product avoid contact with eyes; rinse immediately with cool tap water if contact occurs.

Otc - Do Not Use

Do not use more than the recommended dose or longer than prescribed without checking with your physician. Talk with your physician before you use any other medicines or cleansers on your skin. Ask your physician before prolonged sun exposure. If your symptoms do not improve or they worsen, contact your physician

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

  • Clean the wound before each application
  • Apply a thin layer of Tridergel™ wound care gel to the wound surface and skin immediately surrounding the wound
  • Cover the wound as directed by your physician

Inactive Ingredients

Aloe Barbadensis Leaf Juice Extract, Aminomethyl Propanol, Butylparaben, Carbomer, Decyl Glucoside, Ethylparaben, Glycerin, Hydrolyzed Eggshell Membrane, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Purified Water, Sodium Hyaluronate.

Questions Or Comments

CALL (210) 944-6920

Principal Display Panel - 29.6 Ml Bottle Label

TRIFLUENT
PHARMA®

TRIDERGEL™
WOUND CARE GEL

BENZALKONIUM CHLORIDE

IN A GEL CONTAINING
TRANSFORMING GROWTH
FACTOR – β

NDC 73352-520-01

1.0 FL OZ (29.6 mL)

PRODUCT SHOULD BE ADMINISTERED
UNDER THE SUPERVISION OF A
LICENSED MEDICAL PRACTITIONER

Principal Display Panel (29.6 mL Bottle Label)

Principal Display Panel (29.6 mL Bottle Label)

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