Triple Antibiotic Plus Pain Relief Ointment
FDA Label NDC 50066-202

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa, Inc. for the product Triple Antibiotic Plus Pain Relief (NDC 50066-202). 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, otc - purpose, uses, warnings, do not use, ask a doctor before use if you have, 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:
Genomma Lab USA Inc.
Houston, TX 77098

Otc - Purpose

Active ingredients (in each gram)Purpose
Bacitracin zinc 500 unitsFirst aid antibiotic
Neomycin sulfate 3.5 mgFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
Pramoxine HCl 10 mgExternal analgesic

Uses

first aid to help prevent infection and for the temporary relief of pain in minor:

  • cuts
  • scrapes
  • burns

Warnings

For external use only.

Do Not Use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask A Doctor Before Use If You Have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop Use And Ask A Doctor If

  • you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • 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

  • adults and children 2 years of age and older:
    • 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
    • children under 2 years of age: ask a doctor

Other Information

  • store at 20° to 25°C (68° to 77°F)
  • to open: unscrew cap, pull tab to remove foil seal
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredient

white petrolatum

Questions?

Call toll free 1-877-994-3666Monday to Friday 8am to 6pm, Central time

Principal Display Panel - 28.4 G Tube Carton

cicatricure ®

OPEN WOUND

FOR MINOR CUTS, SCRAPES AND BURNS

PAIN, ITCH & SCAR

  • Triple Antibiotic Ointment
  • Up to 24-Hour Infection Protection
  • Maximum Strength: Infection Protection,
    Pain & Itch Relief
  • Helps Healing Wounds, Minimizing
    the Appearance of Scars**

    • FIRST AID ANTIBIOTIC
    PAIN RELIEVING OINTMENT

    Bacitracin Zinc – Neomycin Sulfate – Polyximin B Sulfate – Pramoxine HCl

    *Based on published studies. For best results use sterile bandage or gauze.
    **Preventing infection helps minimize appearance of scars.

    NET WT.
    1 oz (28.4 g)

    Principal Display Panel (28.4 g Tube Carton)

    Principal Display Panel (28.4 g Tube Carton)

* Please review the disclaimer below.