Bacitracin Zinc
FDA Label NDC 67777-239

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Bacitracin Zinc (NDC 67777-239). 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 otc - active ingredient, uses:, ask a doctor before use:, other information, inactive ingredients, indications & usage, directions:, otc - 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

Otc - Active Ingredient

Active ingredient                   Purpose           
Bacitracin Zinc 500 Units                Antibactrerial

Uses:

First aid to help prevent infection in:
  • Minor cuts
  • scrapes
  • burns

Ask A Doctor Before Use:

  • in case of deep or puncture wounds, animal bites and serious burns
  • if the condition persists or gets worse
  • if a rash or any other allergic reaction develops

Other Information

  • store at controlled room temperature 15°-30° C (59°-86° F)
  • Tamper Evident. Do not use if packet is torn, cut or opened.

Inactive Ingredients

White Petrolatum

Indications & Usage



Indications and Usage

  • For first aid to help prevent infection in minor skin abrasions and rashes.

Directions:

  • clean the affected area
  • apply a small amount of this product (an amount equal to the surface area of the tip of the finger) on the area 1-3 times daily.
  • may be covered with a sterile bandage

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.

Warnings

  • for external use only

    •    

Do Not Use:

Do not use:

  • in the eyes
  • over large area of the body
  • if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock
  • longer than 1 week unless directed by a doctor

Principal Display Panel

Principal Display Panel

Bacitracin_zinc (Bacitracin Zinc)

Bacitracin_zinc (Bacitracin Zinc)

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