FDA Label for Quality Choice Maximum Strength Triple Antibiotic
View Indications, Usage & Precautions
Quality Choice Maximum Strength Triple Antibiotic Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association 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 - Active Ingredient
Active ingredient (in each gram) Purposes
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
Otc - Purpose
Uses
- first aid to help prevent infection and for the temporary relief of pain in minor:
- cuts
- scrapes
- burns
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
- if you are allergic to any of the ingredients
- in the eyes or nose
- over large areas of the body
Otc - Ask Doctor
Ask a doctor before use if you have
- deep or puncture wounds
- animal bites
- serious burns
Otc - Stop Use
Stop use and ask a doctor if
- you need to use longer than 1 week
- rash or other allergic reaction develops
- symptoms persist for more than 1 week, or clear up and occur again within a few days
- condition persists or gets worse
- redness, irritation, swelling, or pain persists or increases
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
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: ask a doctor
Storage And Handling
Other information
- store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
cetyl alcohol, light mineral oil, polyoxyl 40 stearate, stearic acid, white petrolatum
Dosage & Administration
Distributed by:
C.D.M.A., Inc.
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Made in South Korea
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