Active Ingredients
(in each gram)
Bacitracin zinc 400 units
Neoycin sulfate equivalent to 3.5 mg of neomycin base
Polymyxin B sulfate 5,000 units
Ora Zen Triple Antibiotic Ointment
FDA Label NDC 71927-034
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Orazen Inc for the product Ora Zen Triple Antibiotic (NDC 71927-034). 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, purpose, uses, warning, otc - do not use, ask a doctor before use if you have, otc - stop use, 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
Purpose
First Aid antibiotic
First Aid antibiotic
First Aid antibiotic
Uses
First aid to help prevent infection in minor cuts, scrapes, and burns
Warning
For external use only.
Otc - Do Not Use
Do not use
- in the eyes
- internally
- over large areas of the body
- if you are allergic to any of the ingredients
- longer than 1 week unless directed by a doctor
Ask A Doctor Before Use If You Have
- deep puncture wounds, animal bites or serious burns.
Otc - Stop Use
Stop use and ask a doctor if
- the condition persists or gets worse
- a rash or other allergic reaction develops
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center immediately.
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
- store at room temperature (59°-86°F) (do not freeze)
- tamper evident. Do not use if packet is torn, cut or opened.
Inactive Ingredients
White petrolatum
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