TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment

Triple Antibiotic by

Drug Labeling and Warnings

Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Orazen Inc, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each gram)

Bacitracin Zinc         400 units

Neomycin Sulfate    5 mg

(3.5 mg of Neomycin base)

Polymyxin B Sulfate 5000 units

PURPOSE

Purpose

First aid antibiotic

INDICATIONS & USAGE

Uses

first aid to help prevent infection in

• minor cuts
• scrapes
• burns

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use

• in the eyes
• if you are allergic to any of the ingredients
• longer than 1 week unless directed by a doctor
• over large areas of the body

ASK DOCTOR

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

SPL UNCLASSIFIED SECTION

Other Information

• store at room temperature 20°C to 25°C (68°F to 77°C)
• do not use if tube seal under cap is broken, missing or if tube tip is cut prior to opening

INACTIVE INGREDIENT

Inactive Ingredients

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Triple Antibiotic Ointment

Bacitracin Zinc, Neomycin Sulfate and Polymyxin B Sulfate

First Aid Antibiotic Ointment

NET WT 0.5 oz (14.2 g)

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71927-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [USP'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 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COCOA BUTTER (UNII: 512OYT1CRR)
COTTONSEED OIL (UNII: H3E878020N)
OLIVE OIL (UNII: 6UYK2W1W1E)
SODIUM PYRUVATE (UNII: POD38AIF08)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71927-003-02	1 in 1 CARTON	07/12/2018
1		14.2 g 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 final	part333B	07/12/2018

Labeler - Orazen Inc (080916640)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(71927-003)