Active Ingredients (In Each Gram)
Bacitracin Zinc 500units
Neomycin 3.5mg
Polymyxin B Sulfate 10,000 units
Pramoxine HCl 10mg
Antibiotic Plus Pain Relief
FDA Label NDC 67510-0682
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Antibiotic Plus Pain Relief (NDC 67510-0682). 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, do not use, ask a doctor before use if you have, stop use and ask a doctor if, 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
| Active ingredients
(each gram contains) | Purpose |
|---|---|
| Bacitracin zinc 500 units | First aid antibiotic |
| Neomycin sulfate 3.5 mg | First aid antibiotic |
| Polymyxin B sulfate 10,000 units | First aid antibiotic |
| Pramoxine HCI 10 mg | External analgesic |
Uses
First aid to help prevent infection and provide temporary relief of pain or discomfort 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
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
- condition persists for more than 1 week, or clear up and occur again within a few days
- a rash or other allergic reaction develops
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: consult a physician
Other Information
store at 20°-25°C (68°-77°F)
Inactive Ingredients
petrolatum
Principal Display Panel
Triple Antibiotic Ointment + Pain Relief
Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl
First Aid Antibiotic Ointment
Maximum Strength
NET WT 1 oz (28.3 g)
* Please review the disclaimer below.
