NDC 61010-4401

Triple Antibiotic with Pain Relief

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride

Triple Antibiotic with Pain Relief is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Safetec Of America, Inc.. The primary component is Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate; Pramoxine Hydrochloride.

Product ID61010-4401_7dc1aafc-597f-4c18-9e49-383572f1640f
NDC61010-4401
Product TypeHuman Otc Drug
Proprietary NameTriple Antibiotic with Pain Relief
Generic NameBacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2019-11-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333B
Labeler NameSafetec of America, Inc.
Substance NameBACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active Ingredient Strength500 [iU]/g; mg/g; [iU]/g; mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61010-4401-1

28.4 g in 1 TUBE (61010-4401-1)
Marketing Start Date2019-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61010-4401-1 [61010440101]

Triple Antibiotic with Pain Relief OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart333B
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-11-01

Drug Details

Active Ingredients

IngredientStrength
BACITRACIN ZINC500 [iU]/g

NDC Crossover Matching brand name "Triple Antibiotic with Pain Relief" or generic name "Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride"

NDCBrand NameGeneric Name
0363-0123Triple Antibiotic with Pain Reliefbacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride
0363-0823Triple Antibiotic with Pain Reliefbacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride
61010-4401Triple Antibiotic with Pain Reliefbacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride
72288-253basic care first aid antibiotic and burn reliefbacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride
41520-679careone triple antibioticBacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, Pramoxine Hydrochloride
69571-007Family Wellness Antiseptic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE
37205-266LEADER TRIPLE ANTIBIOTIC PLUSBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE
55264-626SHOPKO TRIPLE ANTIBIOTIC PLUSBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE
69842-432Triple Antibiotic and Burn Reliefbacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.