TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin, polymyxin b ointment 
REMEDYREPACK INC.

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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Perrigo Triple Antibiotic Ointment Drug Facts

OTC - ACTIVE INGREDIENT

Bacitracin zinc equivalent to 400 units bacitracin

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 5,000 units as polymyxin B sulfate

 

OTC - PURPOSE

First aid antibiotic

 

INDICATIONS & USAGE

first aid to help prevent infection in minor:

•cuts•scrapes•burns

 

WARNINGS

For external use only.

 

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

 

•deep or puncture wounds•animal bites•serious burns

 

•you need to use longer than 1 week•condition persists or gets worse•rash or other allergic reaction develops

 

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

 

DOSAGE & ADMINISTRATION

•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

 

STORAGE AND HANDLING

•store at 20-25°C (68-77°F)

 

INACTIVE INGREDIENT

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, tocopheryl acetate, white petrolatum

 

OTC - QUESTIONS

1-800-719-9260

 

OTC - KEEP OUT OF REACH OF CHILDREN



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: triple antibiotic


GENERIC: bacitracin zinc, neomycin, polymyxin B


DOSAGE: OINTMENT


ADMINSTRATION: TOPICAL


NDC: 61786-267-04


ACTIVE INGREDIENT(S):

  • BACITRACIN ZINC 400[USP'U] in 1g
  • NEOMYCIN SULFATE 3.5mg in 1g
  • POLYMYXIN B SULFATE 5000[USP'U] in 1g


INACTIVE INGREDIENT(S):

  • .ALPHA.-TOCOPHEROL ACETATE
  • OLIVE OIL
  • SODIUM PYRUVATE
  • COCOA BUTTER
  • COTTONSEED OIL
  • PETROLATUM


COLOR: white


PACKAGING: 14 g in 1 TUBE




MM1

MM2

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin, polymyxin b ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61786-267(NDC:45802-143)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [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 B5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SODIUM PYRUVATE (UNII: POD38AIF08)  
COCOA BUTTER (UNII: 512OYT1CRR)  
COTTONSEED OIL (UNII: H3E878020N)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61786-267-0414 g in 1 TUBE; Type 0: Not a Combination Product04/17/201503/23/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B04/17/201503/23/2017
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2017
 
REMEDYREPACK INC.