Procuretriple Antibiotic Ointment
FDA Label NDC 55681-216

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Twin Med, Llc for the product Procuretriple Antibiotic (NDC 55681-216). 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 ingredients(in each gram), purpose, uses, directions, warnings, do not use, stop use and ask a doctor if, 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 Ingredients(In Each Gram)

Bacitracin Zinc............400 unitsNeomycin Sulfate 5mg(equivalent to 3.5 mg Neomycin)Polymyxin B Sulfate .. 5000 units

Purpose

First Aid Antibiotic

Uses

First aid to prevent infection in
  • Minor cuts
  • Scrapes
  • Burns

Directions

  • Clean the affected area
  • Apply small amount of this product(an amount equal to the surface area of the tip of the finger on the area 1 to 3 times daily
  • May be covered with a sterile bandage

Warnings

For External Use Only.

Do Not Use

  • In the eyes
  • If you are allergic to any of the ingredients
  • Over large areas of the body
  • Longer than 1 week unless directed by a doctor
  • Ask a doctor before use in case of deep or puncture wounds, animal bites or serious burns

Stop Use And Ask A Doctor If

  • The condition persists or gets worse
  • A rash or allergic reaction develops

Keep Out Of Reach Of Children

  • If swallowed, get medical help or contact a Poison Control Centre right away

Other Information

  • Store at controlled room temperature 15o - 30oC(59o--86o F)
  • Avoid excessive heat and humidity
  • Tamper Evident
  • Do not use if packet is torn, cut or opened.

Inactive Ingredients

White Soft Paraffin

Principal Display Panel

ProCure Triple Antibiotic OintmentFirst Aid  Antibiotic144 PACKETSNet Weight: 0.9 gramsItem No. PCTA09NDC # 55681-261-01

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