DRS. PHARMACY TRIPLE ANTIBIOTIC AND BURN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Drs. Pharmacy Triple Antibiotic AND BURN RELIEF by

Drug Labeling and Warnings

Drs. Pharmacy Triple Antibiotic AND BURN RELIEF by is a Otc medication manufactured, distributed, or labeled by OL PHARMA TECH, LLC Drs PHARMACY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Bacitracin zinc 500 units
Neomycin 3.5 mg
Polymyxin B sulfate 10,000 units

Pramoxine hydrochloride 10 mg

Uses

first aid to help prevent infection in minor
cuts
scrapes
burns

Purpose

• first aid antibiotic
• External Analgesic

Do Not Use

Do not use
if you are allergic to any of the ingredients
in the eyes
over large areas of the body
longer than 1 week unless directed by a doctor

WARNINGS

For external use only

ASK DOCTOR

Ask a doctor before use if you have
deep or puncture wounds
animal bites
serious burns

STOP USE

Stop use and ask a doctor if
the condition persists or gets worse
a rash or other allergic reaction develops

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

Petrolatum

QUESTIONS

www.drspharmacyusa.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DRS. PHARMACY TRIPLE ANTIBIOTIC AND BURN RELIEF 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80489-919
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1000 mg
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1000 mg
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1000 mg
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1000 mg

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

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80489-919-01	1 in 1 CARTON	09/05/2021
1		14000 mg in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 80489-919-02	1 in 1 CARTON	09/05/2021
2		28300 mg in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	09/05/2021

Labeler - OL PHARMA TECH, LLC Drs PHARMACY (021170377)

Registrant - OL PHARMA TECH, LLC Drs PHARMACY (021170377)

Establishment
Name	Address	ID/FEI	Business Operations
OL PHARMA TECH, LLC Drs PHARMACY		021170377	manufacture(80489-919)