SUNMARK  TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- polymyxin b sulfate, bacitracin zinc, neomycin sulfate, and pramoxine hydrochloride ointment 
Strategic Sourcing Services LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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sunmark
triple antibiotic plus pain relief

Drug Facts

Active ingredients (in each gram)Purposes
Bacitracin 500 unitsFirst aid antibiotic
Neomycin 3.5 mgFirst aid antibiotic
Polymyxin B 10,000 unitsFirst aid antibiotic
Pramoxine HCl 10 mgTopical pain reliever

Uses

first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

Warnings

For external use only

Do not use if you are allergic to any of the ingredients

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

  • do not use in the eyes
  • do not apply over large areas of the body

Stop use and ask a doctor if

  • you need to use for more 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. If swallowed get medical help or contact a Poison Control Center right away

Directions

Other information

Inactive ingredient

white petrolatum

Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

sunmark

triple antibiotic ointment

plus pain reliever

polymyxin B sulfate • bacitracin zinc
neomycin sulfate • pramoxine hydrochloride

First Aid Antibiotic

MAXIMUM STRENGTH

NET WT 1 OZ (28.4 g)

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
SUNMARK   TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
polymyxin b sulfate, bacitracin zinc, neomycin sulfate, and pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-600
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [iU]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-600-721 in 1 CARTON02/13/2013
128.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/31/2012
Labeler - Strategic Sourcing Services LLC (116956644)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(49348-600)

Revised: 11/2019
Document Id: f48c17ce-818c-45e3-a525-ce3c7c142528
Set id: 941a6a71-e898-4af3-989a-6d3aa3224338
Version: 2
Effective Time: 20191127
 
Strategic Sourcing Services LLC