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

Triple Antibiotic First Aid Antibiotic by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B Sulfate 5000U

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 on

• on deep puncture wounds, animal bites, or serious burns

STOP USE

Stop use and consult a doctor if the condition persists or gets worse, or if 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 and dry thoroughly
• May be covered with a sterile bandage
• 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

SPL UNCLASSIFIED SECTION

Other Information

• Store at 20°C to 25°C (68°F to 77°C)
• Lot No. & Exp. Date: see crimp of tube

INACTIVE INGREDIENT

Inactive Ingredients

cocoa butter, cotton seed oil, olive oil,  sodium pyruvate, vitamin E, white petrolatum, hard parrafin, mineral oil

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Triple Antibiotic First Aid Antibiotic Ointment

NET WT 0.5 OZ (14 g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47046-154
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)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
PARAFFIN (UNII: I9O0E3H2ZE)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47046-154-02	1 in 1 BOX	12/09/2020
1	NDC: 47046-154-01	14 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	12/09/2020

Labeler - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(47046-154)