BACITRACIN ZINC- bacitracin zinc 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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Bacitracin Zinc Ointment USP

OTC - ACTIVE INGREDIENT

Bacitracin Zinc (equal to 500 bacitracin units)

 

OTC - PURPOSE

Antibiotic

 

INDICATIONS & USAGE

Uses:

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

 

WARNINGS

Warnings: For external use only

Do not use

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

Ask doctor before use in case of deep or puncture wounds, animal bites or serious burns

When using this product do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

  • the condition persists or gets worse
  • if a rash or other allergic reaction develops

 

OTC - KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

 

DOSAGE & ADMINISTRATION

Directions:

  • 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

 

SPL UNCLASSIFIED

Other information:

  • do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
  • store at room temperature
  • see crimp of tube for Lot Number and Exp. Date

 

INACTIVE INGREDIENT

white petrolatum

 

SPL UNCLASSIFIED

Questions or comments? call toll free 1-800-645-9833

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Bacitracin Zinc


GENERIC: bacitracin zinc


DOSAGE: OINTMENT


ADMINSTRATION: TOPICAL


NDC: 61786-190-04


ACTIVE INGREDIENT(S):

  • BACITRACIN ZINC 500[USP'U] in 1g


INACTIVE INGREDIENT(S):

  • PETROLATUM


PACKAGING: 14.17 g in 1 TUBE




MM1

MM2

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61786-190(NDC:0168-0011)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61786-190-0414.17 g in 1 TUBE; Type 0: Not a Combination Product02/17/201503/13/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B02/17/201503/13/2016
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2017
 
REMEDYREPACK INC.