Single Antibiotic With Bacitracin Ointment
FDA Label NDC 52412-750

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Randob Labs Ltd. for the product Single Antibiotic With Bacitracin (NDC 52412-750). 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:, otc - keep out of reach of children, do not use:, stop use, ask a doctor if:, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Gram)

Bacitracin zinc (500 units bacitracin)

Purpose

First Aid Antibiotic

Uses:

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

Otc - Keep Out Of Reach Of Children

For external use only. Keep out of reach of children.

If ingested, get medical help or contact a Poison Control Center directly.

Do Not Use:

  • in the eyes or over large areas of the body, or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if allergic to any of the ingredients

Stop Use, Ask A Doctor If:

  • condition persists or gets worse
  • a rash or allergic reaction develops

Directions:

  • clean affected area
  • apply a small amount of this product (equal to the surface area of the tip of finger) 1 to 3 times daily
  • may cover with a sterile bandage

Inactive Ingredients:

mineral oil, petrolatum

Questions Or Comments?

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