Dermacline
FDA Label NDC 71250-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Inventus, Llc for the product Dermacline (NDC 71250-002). 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 (in each gram), purpose, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Gram)

Tetracycline Hydrochloride 30mg

Purpose

First Aid antibiotic

Use

First aid to help prevent skin infection in minor cuts, scrapes, and burns.

Warnings

For esternam 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.

Otc - Keep Out Of Reach Of Children

Keep our 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.

Other Information

  • Keep product refrigerated to preserve its effectiveness and color
  • 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 Ingredient

Acetic Acid, Ascorbic Acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, GLYCERIN, histidine, hydroxethylc-cellulose, magnesium stearate, methylparaben, sodium hydroxide, sorbic acid, steric acid, water.

Label- Dermacline Topical Ointment

Image Description (Dermacline)

Image Description (Dermacline)

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