Triple Antibiotic Ointment
FDA Label NDC 61010-5603

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America, Inc. for the product Triple Antibiotic (NDC 61010-5603). 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), purposes, uses, warnings, do not use:, ask a doctor before use:, stop use and ask a doctor if:, 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 (400 units Bacitracin)

Neomycin Sulfate 5 mg (equivalent to 3.5 mg of Neomycin base)

Polymyxin-B Sulfate 5000 units

Purposes

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Uses

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

Warnings

For external use only

Do Not Use:

  • in the eyes
  • internally
  • 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:

  • in case of deep or puncture wounds, animal bites, or serious burns

Stop Use And Ask A Doctor If:

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

Keep This And All Drugs Out Of The Reach Of Children.

In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

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 Information

  • Store at room temperature (do not freeze)
  • Do Not Use any Opened or Torn Packets

Inactive Ingredient

Petrolatum

Questions Or Comments? 1-800-456-7077

Manufactured by
SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 • 800-456-7077
www.safetec.com

Principal Display Panel – 0.5G Pouch Label

Safetec

Triple Antibiotic Ointment™

0.5 g (1/57 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

Principal Display Panel – Box Label

NDC 61010-5603-4

Safetec

First Aid

Triple Antibiotic Ointment™

First Aid to Help Prevent

Infection In Minor Cuts,

Scrapes, and Burns

Reorder no. 53214

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

* Please review the disclaimer below.