SOFSKIN TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl ointment

SOFSKIN TRIPLE ANTIBIOTIC by

Drug Labeling and Warnings

SOFSKIN TRIPLE ANTIBIOTIC by is a Otc medication manufactured, distributed, or labeled by GOPALDAS VISRAM AND COMPANY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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.

Do not use

• if you are allergic to any of the ingredients
• in the eyes
• over large areas of the body

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

Stop use and ask a doctor if

• 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOFSKIN TRIPLE ANTIBIOTIC  PLUS PAIN RELIEF
bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61040-134
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61040-134-11	1 in 1 BOX	07/15/2024
1	NDC: 61040-134-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	07/15/2024

Labeler - GOPALDAS VISRAM AND COMPANY LIMITED (858030888)