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Drug Facts
Maximum Strength Triple Antibiotic
FDA Label NDC 81238-4605
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Western First Aid Safety Dba Aramark for the product Maximum Strength Triple Antibiotic (NDC 81238-4605). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients:
(Bacitracin Zinc-Neomycin-Polymyxin B)
Otc - Purpose
First aid antibiotic plus topical pain reliever.
Indications & Usage
Uses:
First aid to help prevent infection and for the
temporary relief of pain or discomfort in minor cuts,
scrapes, and burns.
Warnings
Warnings: For external use only.
Do Not Use:
• In the eyes • Over large areas of the body
• Longer than 1 week unless directed by doctor
• If you are allergic to any of the ingredients,
due to the possibility of anaphylactic shock
Otc - Stop Use
Stop Use and Ask a Doctor: • Before use in
case of deep puncture wounds, animal bite or serious
burns. • If the condition perists or gets worse. • If a
rash or other allergic reaction develops.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Dosage & Administration
Directions: Clean the aff¬ected area. Apply a small
amount of this product (an amount equal to the tip of
a finger) on the area 1 to 3 times daily. May be covered
with sterile bandage. Children under 2 years of age
consult a physician.
Other Safety Information
Ingredients:
NET WT: 1 gm Each gram contains 400 units of
Bacitracin Zinc. Neomycin Sulfate equivalent to 3.5 mg
of Neomycin base. 5,000 units of Polymyxin B Sulfate
in a white petrolatum base.
Inactive Ingredient
Inactive Ingredients: Petrolatum, Mineral oil, Purified water
Principal Display Panel
aramark
6 ct. of 1g packets
MAXIMUM STRENGTH TRIPLE
ANTIBIOTIC OINTMENT
UNIT DOSE - ANTI-INFECTION TRIPLE ACTION: BACITRACIN ZINC,
NEOMYCIN & POLYMYXIN B.
aramarkuniform.com
MANUFACTURED BY:
Aramark
Lenexa, KS 66219 (913) 269-9611
6 Count
25 Count
res
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