Triple Antibiotic (First Aid Antibiotic) Ointment [Dynarex Corporation] -

TRIPLE ANTIBIOTIC (FIRST AID ANTIBIOTIC) OINTMENT [DYNAREX CORPORATION]
PDF | XML

NDC	67777-118-40
Set ID	7f941c9c-bccf-5b05-e053-2a91aa0a6e21
Category	HUMAN OTC DRUG LABEL
Packager	Dynarex Corporation
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

View All Sections

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

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC
first aid antibiotic ointment

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 in 1000 mg
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg in 1000 mg
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 in 1000 mg

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67777-118-40	72 in 1 CASE	01/23/2018
1		14000 mg in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	01/23/2018

Labeler - Dynarex Corporation (008124539)

View All Sections

Medic