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  5. Label Information: Triple Antibiotic Plus

FDA Label for Triple Antibiotic Plus

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH GRAM)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENT
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Triple Antibiotic Plus Product Label

The following document was submitted to the FDA by the labeler of this product Cosette Pharmaceuticals, 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.

Active Ingredient (In Each Gram)



Bacitracin zinc 500 units
Neomycin 3.5 mg
Polymyxin B sulfate 10,000 units
Pramoxine hydrochloride 10.0 mg


Purpose



First Aid Antibiotic
Topical 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
• longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have
• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if
• the condition persists or gets worse
• a rash or other allergic reaction develops
• symptoms persist for more than 1 week, or clear up and occur again within a few days


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 doctor


Other Information



store at room temperature


Inactive Ingredient



light mineral oil, white petrolatum


Package Label.Principal Display Panel



G&W
Triple Antibiotic Plus Ointment
Polymyxin B Sulfate • Bacitracin Zinc • Neomycin Sulfate • Pramoxine HCl
First Aid Antibiotic / Pain Relieving Ointment
NET WT. 1 oz (28.4g)


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