• Active Ingredient
Bacitracin zinc 400 units
Neomycin sulfate 5 mg (equivalent to 3.5 mg. of neomycin base)
Polymyxin - B sulfate 5000 units
Triple Antibiotic Ointment
FDA Label NDC 0924-5610
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Acme United Corporation for the product Triple Antibiotic (NDC 0924-5610). 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 ingredient, otc - purpose, • uses, warnings, do not use, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredient (in each gram) | Purpose |
|---|---|
| Bacitracin Zinc 400 Units | First Aid Antibiotic |
| Neomycin Sulfate 5mg (Equivalent to 3.5 mg of Neomycin base) | First Aid Antibiotic |
| Polymyxin B Sulfate 5000 Units | First Aid Antibiotic |
• Uses
First aid to help prevent infection in minor:
- cuts
- scrapes
- burns
Warnings
For external use only
Do Not Use
Do not use • in the eyes •over large areas of the body •if you are allergic to any of the ingredients
•longer than 1 week unless directed by a doctor •on deep lacerations or puncture wounds, animal bites, or serious burns
Stop Use And Ask A Doctor If
•condition persists or gets worse •a rash or allergic reaction occurs
•condition persists for more than 7 days
Otc - Keep Out Of Reach Of Children
Keep out the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Adults and Children Clean the affected area. Apply a small amount of product
(equal to the surface area of a fingertip) 1 to 3 times daily. May be covered with a sterile bandage.
Other Information
Store at 15°- 30°C (59°- 86°F)
Inactive Ingredient
White Petrolatum
Otc - Questions
Questions 1.800.835.2263
Package Label.Principal Display Panel
Carton Image
Carton Image (807709 Reva Fda)
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