Vitastem-tetracycline Hydrochloride Spray
FDA Label NDC 71262-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Viaderma Distribution, Inc. for the product Vitastem-tetracycline Hydrochloride (NDC 71262-003). 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, indications:, warnings:, do not use, ask a doctor before use if you have, stop use and ask a doctor, 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

Active Ingredient

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 is 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.

Inactive Ingredients:

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

Package Labeling:

Box (Box)

Box (Box)

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