Tetracyte Topical
FDA Label NDC 79790-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wounds Pros, Llc for the product Tetracyte Topical (NDC 79790-001). 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, active ingredient (in each gram), purpose, indications, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Gram)

Tetracycline-HCL 30mg

Purpose

First Aid/Antibiotic

Indications

First aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns.

Warnings

For external use only. May be harmful if swallowed.

Allergy Alert
Do not use if allergic to any ingredient listed on this label.

Do Not Use

  • in eyes 
  •  over large areas of the body 
  • longer than 1 week unless directed by doctor

Ask A Doctor Before Use If You Have

  • deep or puncture wounds
  • animal bites
  • serious trauma

Stop Use And Ask A Doctor

if condition persists or gets worse.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison control Center right away.

Directions

  • clean the affected area
  • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Stop Use If Product Is Misused

  • this product is an OTC antibiotic for human use 
  • contains no alcohol, no animal ingredients
  • blended for typical skin color 
  • may stain cloth 
  • no claims regarding stem cell healing are implied for this product

Other Information

  • For best results refrigerate or store in a cool dark place.

Inactive Ingredients

acetic acid, ascorbic acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, glycerin, histidine, hydroxethyl-cellulose, magnesium stearate, sodium hydroxide, sorbic acid, stearic acid, water

Package Labeling:

Bottle2 (Bottle2)

Bottle2 (Bottle2)

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