Active Ingredients
Bacitracin Zinc (500 units)
Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin)
Polymyxin B Sulfate (10,000 units)
Pramoxine Hydrochloride (10 mg)
Sofskin Triple Antibiotic
FDA Label NDC 61040-134
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gopaldas Visram And Company Limited for the product Sofskin Triple Antibiotic (NDC 61040-134). 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 ingredients, purpose, uses, warnings, otc - 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
Purpose
First aid antibiotic
First aid antibiotic
First aid antibiotic
External analgesic
Uses
First aid to help prevent infection and for the temporary relief of pain in minor:
- cuts
- scrapes
- burns
Warnings
- For external use only.
- if you are allergic to any of the ingredients
- in the eyes
- over large areas of the body
- 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
Do not use
Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.
Stop use and ask a doctor if
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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: ask a doctor
Other Information
- do not use if seal on the tube is damaged or is not visible
- to open, unscrew cap, pull tab to remove foil seal
- store at 20° to 25°C (68° to 77°F)
- avoid excessive heat and humidity
- see crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredient
WHITE PETROLATUM
Package Label.Principal Display Panel
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