Bacitracin Zinc Ointment
FDA Label NDC 58980-011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Stratus Pharmaceuticals Inc for the product Bacitracin Zinc (NDC 58980-011). 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 other, active ingredient (in each gram), purpose, uses, warnings, allergy alert, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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Drug Facts

Distributed by: Stratus Pharmaceuticals Inc.
12379 SW 130th Street
Miami, Florida 33186

Active Ingredient (In Each Gram)

Bacitracin Zinc, USP 500 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only

Allergy Alert

  • do not use if allergic to any of the ingredients

Do Not Use

  • 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

When Using This Product

  • do not use longer then one week unless directed by doctor

Stop Use And Ask A Doctor If

  • condition persists or gets worse
  • a rash or other allergic reaction develop

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Clean 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
  • May be covered with a sterile bandage

Other Information

  • Store at room temperature 59°F - 77°F (15°C - 25°C)
  • Before using any medication, read all label directions. Keep carton, it contains important information.
  • Do not use if seal is punctured or is not visible
  • See crimp of tube and outside of carton for Lot Number and Expiration Date.
  • To open, reverse cap and puncture.

Inactive Ingredient

White petrolatum

Questions Or Comments?

Call toll-free 1-800-442-7882

Principal Display Panel - 28.35 G Tube Box

STRATUSCARE
NDC 58980-011-10

Bacitracin Zinc Ointment USP

First Aid Antibiotic

Net Wt. 1.0 OZ (28.35 g)

Distributed by:
STRATUS
PHARMACEUTICALS INC

Principal Display Panel (28.35 g Tube Box)

Principal Display Panel (28.35 g Tube Box)

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