TRIPLE ANTIBIOTIC- 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.

----------

1184 Triple Antibiotic NDC 67777-118-40

Active Ingredients

Bacitracin Zinc (400 units per gram)

Neomycin Sulfate 5mg (equivalent to 3.5mg Neomycin per gram)

Polymyxin B Sulfate (5000 units per gram)

Purpose

First Aid Antibiotics

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

Store at room temperature.

Inactive Ingredient

White Petrolatum

Label

1184 Triple Antibiotic NDC 67777-217-03

TRIPLE ANTIBIOTIC 
first aid antibiotic ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-118
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400   in 1000 mg
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1000 mg
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000   in 1000 mg
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-118-4072 in 1 CASE01/23/2018
114000 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/23/2018
Labeler - Dynarex Corporation (008124539)

Revised: 2/2019
Document Id: 81558d4b-c9d1-5ccb-e053-2a91aa0a67f6
Set id: 7f941c9c-bccf-5b05-e053-2a91aa0a6e21
Version: 2
Effective Time: 20190207
 
Dynarex Corporation