Triple Antibiotic With Pain Relief Ointment
FDA Label NDC 61010-4401

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 With Pain Relief (NDC 61010-4401). 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 ingredients (in each gram), purpose, uses, warnings, do not use, otc - ask doctor, 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 Ingredients (In Each Gram)

Bacitracin Zinc (500 units)

Neomycin Sulfate 5mg (3.5mg Neomycin)

Polymyxin B Sulfate (5000 units)

Pramoxine Hydrochloride (10mg)

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Pain Reliever

Uses

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

Warnings

For external use only

Do Not Use

  • In the eyes
  • If you are allergic to any of the ingredients
  • Over large areas of the body
  • Longer than 1 week unless directed by a doctor

Otc - Ask Doctor

Ask a doctor before use if you have 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

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. Apply a small amount (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

Inactive Ingredients

White Petrolatum

Principal Display Panel - 1 Oz. Tube Label

Safetec®

Triple Antibiotic Ointment
with Pain Relief

Net Wt. 1 oz. (28.4g)

Reorder No. 53206

Manufactured for: Safetec of America, Inc.
Buffalo, NY 14215 | 1-800-456-7077

Made in India KD/503

Principal Display Panel (1 oz. Tube Label)

Principal Display Panel (1 oz. Tube Label)

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