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Drug Facts
Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901
Manufactured in India
MH/DRUGS/28-KD/503
Triple Antibiotic Ointment
FDA Label NDC 68071-3754
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nucare Pharmaceutical, Inc. for the product Triple Antibiotic (NDC 68071-3754). 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, otc - do not use, otc - ask doctor, otc - stop use, 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
Otc - Purpose
| Active ingredients (in each gram) | Purpose |
|---|---|
| Bacitracin zinc USP 400 units | First aid antibiotic |
| Neomycin sulfate USP 3.5 mg | First aid antibiotic |
| Polymyxin B sulfate USP 5,000 units | First aid antibiotic |
Uses
first aid to help prevent infection in minor:
- cuts
- scrapes
- burns
Warnings
For external use only.
Otc - Do Not Use
Do not use
- if you are allergic to any of the ingredients
- in the eyes
- over large areas of the body
Otc - Ask Doctor
Ask a doctor before use if you have
- deep or puncture wounds
- animal bites
- serious burns
Otc - Stop Use
Stop use and ask a doctor if
- you need to use longer than 1 week
- condition persists or gets worse
- 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 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 20° to 25°C (68° to 77°F)
- see carton or tube crimp for lot number and expiration date
Inactive Ingredients
cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum
Questions?
Call 1-866-923-4914
Principal Display Panel - 28.4 G Tube Carton
Jpg (68071 3754 1)
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