TRIPLE ANTIBIOTIC PLUS PAIN RELIEF - bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment 
Navarro Discount Pharmacies,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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Drug Facts

Active ingredients (in each gram)

Bacitracin Zinc 500 units
Neomycin 3.5mg
Polymyxin B Sulfate 10,000 units
Pramoxine HCl 10mg

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic

Uses

First aid to help prevent infection and provide 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
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • condition persists or gets worse
  • condition persists for more than 1 week, or clear up and occur again within a few days
  • a 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

store at 20°-25°C (68°-77°F)

Inactive ingredient

white petrolatum

PRINCIPAL DISPLAY PANEL

Triple Antibiotic Ointment Plus Pain Reliefimage of carton label

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59970-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  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 [USP'U]  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:59970-040-011 in 1 CARTON
128.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B08/01/2012
Labeler - Navarro Discount Pharmacies,LLC (094930963)

Revised: 8/2012
Document Id: b93ed0aa-2efa-414c-ad54-64c1a147f53b
Set id: 50085398-7ffd-485f-9d60-f7252fa5c9b9
Version: 1
Effective Time: 20120801
 
Navarro Discount Pharmacies,LLC