FDA Label for Triple Antibiotic
View Indications, Usage & Precautions
Triple Antibiotic Product Label
The following document was submitted to the FDA by the labeler of this product Anicare Pharmaceuticals Pvt. Ltd. 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 - Active Ingredient
Active Ingredients (in each gram)
Bacitracin Zinc 400 units
Neomycin Sulfate 5 mg
(3.5 mg of Neomycin base)
Polymyxin B Sulfate 5000 units
Otc - Purpose
Purpose
First aid antibiotic
Indications & Usage
Uses
first aid to help prevent infection in
- minor cuts
- scrapes
- burns
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use
- in the eyes
- if you are allergic to any of the ingredients
- longer than 1 week unless directed by a doctor
- over large areas of the body
Otc - Ask Doctor
Ask a doctor before use if you have deep or 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
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.
Dosage & Administration
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
Other Information
- store at room temperature 20°C to 25°C (68°F to 77°C)
- do not use if tube seal under cap is broken, missing or if tube tip is cut prior to opening
Inactive Ingredient
Inactive Ingredients
cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL
Triple Antibiotic Ointment
Bacitracin Zinc, Neomycin Sulfate and Polymyxin B Sulfate
First Aid Antibiotic Ointment
NET WT 0.5 oz (14.2 g)
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