Warnings
For external use only.
Triple Antibiotic
FDA Label NDC 82199-530
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 Ruian Pharmaceutical Co.,ltd. for the product Triple Antibiotic (NDC 82199-530). 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 warnings, inactive ingredient, otc - do not use, otc - keep out of reach of children, otc - purpose, otc - ask doctor, otc - active ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
white petrolatum
Otc - Do Not Use
• if you are allergic to any of the ingredients
• in the eyes
• over large areas of the body
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Otc - Purpose
First aid antibiotic
External analgesic
Otc - Ask Doctor
• deep or puncture wounds
• animal bites
• serious burns
Otc - Active Ingredient
POLYMYXIN B SULFATE;
NEOMYCIN SULFATE;
BACITRACIN ZINC;
PRAMOXINE HYDROCHLORIDE
Other Safety Information
store at 10-30°C
Dosage & Administration
• adults and children 2 years of age or 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
Indications & Usage
first aid to help prevent infection and for temporary relief of pain or discomfort in minor:
• cuts
• scrapes
• burns
Package Label.Principal Display Panel
NDC:82199-528-15 14.2 g in 1 TUBE
NDC:82199-528-16 28.3 g in 1 TUBE
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