Label: SOFSKIN TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl ointment
- NDC Code(s): 61040-134-01, 61040-134-11
- Packager: GOPALDAS VISRAM AND COMPANY LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 10, 2024
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- ACTIVE INGREDIENTS
- PURPOSE
- USES
-
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
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SOFSKIN TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl ointmentProduct 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)