Topcare Ointment
FDA Label NDC 36800-089

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare (NDC 36800-089). 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 (each gram contains), purpose, uses, otc - do not use, ask a doctor before use, stop use and ask a doctor if, 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

Other

Drug Facts

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD
SKOKIE, IL 60077

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

Otc - Do Not Use

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

  • on deep or puncture wounds, animal bites, or serious burns

Stop Use And Ask A Doctor If

  • 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.

Directions

  • clean the affected area and dry thoroughly
  • 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

  • To open: unscrew cap, pull tab to remove foil seal
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

mineral oil, white petrolatum

Questions?

1-888-423-0139

Principal Display Panel - 28.4 G Tube Carton

TopCare®

FIRST AID ANTIBIOTIC

Bacitracin Zinc
Ointment USP

QUALITY
GUARANTEED

NET WT 1 OZ (28.4 g)

Principal Display Panel (28.4 g Tube Carton)

Principal Display Panel (28.4 g Tube Carton)

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