THERA PLUS ORIGINAL STRENGTH TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Thera Plus Original Strength Triple Antibiotic by

Drug Labeling and Warnings

Thera Plus Original Strength Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Fourstar Group USA, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each gram)

Bacitracin zinc 400 units 
Neomycin sulfate 3.5 mg
Polymyxin B sulfate 5,000 units

Purpose

First aid antibiotic

Uses

for first aid to help to prevent infection in minor:  cuts  scrapes  burns

Warnings

For external use only.

Do not use

if you are allergic to any of the ingredients in this product  in contact with the eyes or mucous membranes  over large areas of the body  longer than 1 week unless directed by a doctor

When using this product

avoid contact with eyes

Ask a doctor before use if you have

deep or puncture wounds  animal bites  serious burns

Stop use and ask a doctor if

symptoms last for more than 7 days  the conditions persists or gets worse  symptoms clear up and the occur again within a few days  a rash or other allergic reaction occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Adults and children 2 years of age and older:  clean the affected area  apply a small amount of this product (an amount equal to the surface area of the tip of a finger) to affected area 1 to 3 times daily  may be covered with a sterile bandage.  children under 2 years of age: ask a doctor before use

Other information

store at room temperature 59°- 77° F (15°-25°C).

Inactive ingredients

white petrolatum

Questions?

1-800-639-3803Weekdays 9 AM to 4 PM EST

Package Labeling:

INGREDIENTS AND APPEARANCE

THERA PLUS ORIGINAL STRENGTH TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80684-198
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 U  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 U  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80684-198-00	6 in 1 BOX	11/20/2025
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	11/20/2025

Labeler - Fourstar Group USA, Inc (140099503)

Registrant - Fourstar Group USA, Inc (140099503)