Penimixcina Ointment
FDA Label NDC 69729-615

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Penimixcina (NDC 69729-615). 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 active ingredients (in each gram), purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Gram)

BACITRACIN ZINC  500 UNITS

NEOMYCIN SULFATE  5 MG  (EQUIVALENT TO 3.5 MG NEOMYCIN)

POLYMYXIN B SULFATE  5000 UNITS

PRAMOXINE HYCHLORIDE  10 MG

Purpose

FIRST AID ANTIBIOTIC

PAIN RELIEVER

Uses

  • FIRST AID TO HELP PREVENT INFECTION IN
  • MINOR CUTS
  • SCRAPES
  • 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

    • ASK A DOCTOR BEFORE USE IN CASE OF

    • DEEP OR PUNCTURE WOUNDS
    • ANIMAL BITES
    • OR SERIOUS BURNS

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

  • If swallowed get medical help or contact Poison Control Center right away.

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

Inactive Ingredients

WHITE PETROLATUM

Other Information

  • STORE AT 15° - 30°C (59°F - 86°F)
  • AVOID EXCESSIVE HEAT AND HUMIDITY

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