FDA Label for Leader Triple Antibiotic Plus
View Indications, Usage & Precautions
Leader Triple Antibiotic Plus Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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) 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 hydrochloride 10
mg........................................................................Pain
reliever
Otc - Purpose
Uses
help prevent infection and temporarily relieves pain due to
- minor cuts
- scrapes
- burns
Warnings
Warnings
For external use only
Allergy alert: do not use if allergic to any of the ingredients
Otc - Do Not Use
Do not use
- in or near the eyes
- over large areas of the body
- longer than 1 week
Otc - Ask Doctor
Ask a doctor before use in case of deep or puncture wounds,
animal bites, or serious burns
Otc - When Using
When using this product do not use longer than 1 week
Otc - Stop Use
Stop use and ask a doctor if
- condition persists or gets worse
- symptoms last for more than 7 days or clear up and comes back within a few days
- a rash or other allergic reaction occurs
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.
Indications & Usage
Directions
Adults and children 2 years and older:
- clean affected area
- apply a small amount (equal to the surface area of the tip of a finger) on area 1 to 3 times daily
- may be covered with a sterile bandage
Storage And Handling
Other information
- store at 15 o to 25 o C (59 o to 77 o F)
- Lot No. and Exp. Date: see box or crimp of tube
Inactive Ingredient
Inactive ingredients
white petrolatum, water
Dosage & Administration
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
CIN 2372167
www.myleader.com
1-800-200-6313
Made in Korea
Package Label.Principal Display Panel
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