BACITRACIN ZINC- first aid antibiotic 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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1171 Bacitracin Zinc Ointment NDC 67777-008-10
1172 Bacitracin Zinc Ointment NDC 67777-008-20
1173 Bacitracin Zinc Ointment NDC 67777-008-30
1175 Bacitracin Zinc Ointment NDC 67777-008-50
1176 Bacitracin Zinc Ointment NDC 67777-008-60

Active Ingredient

Bacitracin Zinc (500 units in each gram)

Purpose

First Aid Antibiotic

Uses

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

Stop use and ask a doctor if

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

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

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

1171 Label

1171 BX MASTER

1172 Label

1172 Bacitracin Zinc

1173 Label

1173 Bacitracin Zinc Ointment

1175 Label

1175 Bacitracin Zinc

1176 Label

1176 Bacitracin Zinc

BACITRACIN ZINC 
first aid antibiotic ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-008
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)  
PETROLATUM (UNII: 4T6H12BN9U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-008-101728 in 1 CASE02/16/2018
1144 in 1 BOX
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:67777-008-2072 in 1 CASE02/16/2018
21 in 1 BOX
214.2 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:67777-008-3072 in 1 CASE02/16/2018
31 in 1 BOX
328.4 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:67777-008-5072 in 1 CASE02/16/2018
41 in 1 BOX
4113 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:67777-008-6012 in 1 CASE02/16/2018
5425 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B02/16/2018
Labeler - Dynarex Corporation (008124539)

Revised: 9/2020
Document Id: af9aa56d-2f91-55b9-e053-2a95a90a3258
Set id: 82cf8dd0-eef6-5871-e053-2991aa0a38cf
Version: 3
Effective Time: 20200918
 
Dynarex Corporation