Zapotol Bacitracin Cream
FDA Label NDC 59428-135

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zapatol Corp. for the product Zapotol Bacitracin (NDC 59428-135). 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, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - keep out of reach of children, indications & usage, 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 (each gram contains)                                      Purpose

Bacitracin 500 units.....................................................................First Aid Antibiotic

Otc - Purpose

Uses

First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

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

Otc - Ask Doctor

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

Otc - Stop Use

Stop use and ask a doctor if

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

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.

Indications & Usage

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 Safety Information

Other Information

  • Store at 15°C to 25°C (59°F to 77°F)
  • Lot NO., & Exp. Date: see box or see crimp to tube

Inactive Ingredient

Inactive ingredients

aloe vera gel, light mineral oil and white petrolatum

Dosage & Administration

DISTRIBUTED BY:

Productos Zapotol Corp.

Van Nuys, CA 91402 888-927-6865

Made in Korea

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