Fifthpulse Bacitracin Zinc Ointment
FDA Label NDC 87525-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wecare Products Llc for the product Fifthpulse Bacitracin Zinc (NDC 87525-001). 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 (each gram contains), purpose, uses, warnings, do not use, ask a doctor before use, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (Each Gram Contains)

Bacitracin Zinc 500 units

Purpose

First Aid Antibiotic

Uses

First aid to help prevent infection in minor
• cuts
• scrapes
• burns

Warnings

For external use only.

Do Not Use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor.

Ask A Doctor Before Use

in care of deep puncture wounds, animal bites, or serious burns.

Stop Use And Ask A Doctor If

  • the condtions 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 Center immediately.

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 between 15° to 25° C (59° to 77°F)
  • Lot No & Expiration Date: See box and tube crimp.

Inactive Ingredients

Mineral oil, Petrolatum

Questions Or Comments?

Please call 1-888-209-5201

Package Labeling:

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