LINCOLN- bacitracin zinc ointment 
Lincoln Pharmaceuticals Ltd.

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 Ingredient (in each gram)

Bacitracin Zinc (equal to 500 bacitracin units)

Drug Facts

First Aid Antibiotic

Drug Facts

Uses

Drug Facts

For External use only

Do not use

Drug Facts

  • deep or puncture wounds
  • animal bites
  • serious burns

Drug Facts

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

Drug Facts

Keep out of reach of children

Drug Facts

Drug Facts

Other information:

Drug Facts

Inactive ingredients

hard paraffin, liquid paraffin, white soft paraffin, lanolin

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LINCOLN 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69636-3035
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
MINERAL OIL (UNII: T5L8T28FGP)  
LANOLIN (UNII: 7EV65EAW6H)  
PETROLATUM (UNII: 4T6H12BN9U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69636-3035-20.9 g in 1 PACKET; Type 0: Not a Combination Product05/30/2013
2NDC:69636-3035-314 g in 1 TUBE; Type 0: Not a Combination Product05/30/2013
3NDC:69636-3035-428 g in 1 TUBE; Type 0: Not a Combination Product05/30/2013
4NDC:69636-3035-5113 g in 1 TUBE; Type 0: Not a Combination Product05/30/2013
5NDC:69636-3035-6425 g in 1 JAR; Type 0: Not a Combination Product05/30/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B05/30/2013
Labeler - Lincoln Pharmaceuticals Ltd. (915839373)
Establishment
NameAddressID/FEIBusiness Operations
Lincoln Pharmaceuticals Ltd915839373manufacture(69636-3035)

Revised: 4/2016
Document Id: 2fb062c7-d75f-4c42-e054-00144ff88e88
Set id: 2fb062c7-d75e-4c42-e054-00144ff88e88
Version: 1
Effective Time: 20160408
 
Lincoln Pharmaceuticals Ltd.