FDA Label for Triple Antibiotic Plus Pain Relief
View Indications, Usage & Precautions
Triple Antibiotic Plus Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Taro Pharmaceuticals U.s.a., Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - 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 HCl 10 mg | External analgesic |
Uses
first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:
- cuts
- scrapes
- burns
Warnings
For external use only.
Do Not Use
- in the eyes
- over large areas of the body
- if you are allergic to any of the ingredients.
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
- symptoms persist for more than 1 week, or clear up and occur again within a few days
- a 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
Adults and children 2 years of age and older:
- clean the affected area and dry thoroughly
- 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: ask a doctor
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 Ingredient
white petrolatum
Questions?
Call 1-866-923-4914
Principal Display Panel - 28.4 G Tube Label
First Aid Antibiotic
Pain Relieving Ointment
Maximum Strength
Triple Antibiotic
Ointment + Pain
Relief
Bacitracin Zinc ∙ Neomycin Sulfate
Polymyxin B Sulfate ∙ Pramoxine Hydrochloride
NET WT 1 oz (28.4 g)
* Please review the disclaimer below.