TRIPLE ANTIBIOTIC MAXIMUM STRENGTH- bacitracin zinc neomycin polymyxin b sulfate ointment

Triple Antibiotic by

Drug Labeling and Warnings

Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Budpak Inc. , Nantong Zhongbao Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Bacitracin Zinc 400U
Neomycin 3.5mg
Polymyxin B sulfate 5000U

PURPOSE

Purpose
First Aid Antibiotic
First Aid Antibiotic
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
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 68 to 77F (20C-25C)  See carton or tube crimp for lot number and expiration date

INACTIVE INGREDIENT

Inactive ingredients Petrolatum, Mineral oil, Ozocerite, Propanediol, Methylparaben, Propylparaben

PRINCIPAL DISPLAY PANEL

Package Label

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC  MAXIMUM STRENGTH
bacitracin zinc neomycin polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-014
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
PROPANEDIOL (UNII: 5965N8W85T)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-014-01	1 in 1 BOX
1	NDC: 27293-014-14	14 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	08/19/2011

Labeler - Budpak Inc. (183224849)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Zhongbao Pharmaceutical Co., Ltd		420795668	manufacture