BACITRACIN- bacitracin ointment 
Dynarex Corporation

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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1161 Bacitracin NDC 67777-116-10
1162 Bacitracin NDC 67777-116-20
1163 Bacitracin NDC 67777-116-30

Active Ingredient

Bacitracin (500 units in each gram)

Purpose

First Aid Antibiotic

Use

First aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

For External Use Only

Do not use

  • In the eyes or apply over large areas of the body
  • If you are allergic to any of the ingredients
  • Longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

deep or puncture wounds, animal bites, or serious burns

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

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.

Other information

Store at room temperature

Inactive ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Label

1161 BX MASTER1161 Bacitracin Ointment

Label

1162 BX MASTER1162 Bacitracin Ointment

Label

1163 BX MASTER1163 Bacitracin Ointment

BACITRACIN 
bacitracin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-116
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-116-2072 in 1 CASE09/12/2016
1NDC:67777-116-2114000 mg in 1 TUBE; Type 0: Not a Combination Product
2NDC:67777-116-101728 in 1 CASE09/12/2016
2NDC:67777-116-11144 in 1 BOX
2900 mg in 1 PACKET; Type 0: Not a Combination Product
3NDC:67777-116-3072 in 1 CASE09/12/2016
3NDC:67777-116-311 in 1 BOX
328400 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/12/2016
Labeler - Dynarex Corporation (008124539)

Revised: 11/2022
Document Id: ee14852d-77f0-7452-e053-2a95a90a121e
Set id: 7f8752c7-6839-261d-e053-2991aa0a0c30
Version: 9
Effective Time: 20221122
 
Dynarex Corporation