Otc - Active Ingredient
Polymyxin B sulfate 5000units
Neomycin sulfate 3500units
Bacitracin 500units
Lidocaine hydrochloride 40mg
Triple Antibiotic
FDA Label NDC 82695-0001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shandong Teking Pharmaceutical Co., Ltd for the product Triple Antibiotic (NDC 82695-0001). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
First aid antibiotic
First aid antibiotic
First aid antibiotic
External analgesic
Indications & Usage
First aid to help prevent infection and for the temporary relief of pain in minor:
- cuts
- scrapes
- burns
- surgical wound
Warnings
For external use only
Otc - Do Not Use
- If you are allergic to any of the ingredients
- In the eyes
- Over large areas of the body
Otc - Ask Doctor
- Deep or puncture wounds
- Animal bites
- Serious burns
Otc - Stop Use
- You need to use longer than 1 week
- Condition persists or gets worse
- Symptoms persist for more than 1 week, or clear up and occur again within a few days
- Rash or other allergic reaction develops
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- Adults and children 2 years of age and older:
- Children under 2 years of age: ask a doctor
- 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 2 to 4 times daily and 5 days as a course of treatment.
Other Safety Information
- Store at 10℃-30℃
Inactive Ingredient
Light mineral oil
White petrolatum
Package Label.Principal Display Panel
TRIPLE ANTIBIOTIC OINTMENT
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