Triple Antibiotic Plus Ointment
FDA Label NDC 0713-0622

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosette Pharmaceuticals, Inc. for the product Triple Antibiotic Plus (NDC 0713-0622). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each gram), purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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