Vitacilina First Aid Antibiotic Ointment
FDA Label NDC 81929-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Taisho Pharmaceutical California Inc. for the product Vitacilina First Aid Antibiotic (NDC 81929-003). 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 (in each gram), purpose, use, warnings, do not use, ask a doctor before use if you have, 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 Ingredient (In Each Gram)

Bacitracin Zinc 400 units

Neomycin sulfate 3.5 mg

Polymyxin B sulfate 5,000 units

Purpose

First aid antibiotic

Use

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

Warnings

For external use only.

Do Not Use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask A Doctor Before Use If You Have

  • deep or puncture wounds 
  • animal bites 
  • serious burns

Stop Use And Ask A Doctor If

  • you need to use longer than 1 week 
  • condition persists to gets worse
  • rash or other allergic reaction develops

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center 

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

  • store at 15 to 30°C (59 to 86°F )
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive Ingredient

petrolatum

Package Labeling 28G

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