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

Triple Antibiotic Ointment by

Drug Labeling and Warnings

Triple Antibiotic Ointment by is a Otc medication manufactured, distributed, or labeled by NeoPharm Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 units

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Uses

First aid to help prevent infection in minor:

• cuts
• scrapes
• burns
  

Warnings

For external use only
Do not use if you are allergic to any of the ingredients

Ask a doctor before use if you have

• serious burns
• deep or puncture wounds
• animal bites
  

When using this product

• do not use in the eyes
• do not apply over large areas of the body
  

Stop use and ask a doctor if

• you need to use more than 1 week
• condition persists or gets worse
• symptoms persist for more than 1 week or clear up and occur again within a few days.
• rash or other allergic reaction develops
  

Keep out of reach of children.

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

Directions

• adults and children 2 years of age or older:
• • clean the affected area
  • apply a small amount of this product (an amount equal tot the surface area of the tip of a finer) on the area 1 to 3 times daily
  • may be covered with a sterile bandage
• children under 2 years of age:  ask a doctor
  

Other information

• store at 59° to 77°F

Inactive ingredients

Cetyl alcohol, Glycerin, Light mineral oil, Myristoyl/palmitoyl oxostearamide/ arachamide MEA, Steareth-w, Squalane, Stearic acid, Tocopheryl acetate, White petrolatum

Package label panel

Triple Antibiotic Ointment

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-0070
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 SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	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
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
STEARETH-2 (UNII: V56DFE46J5)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-0070-1	1 in 1 BOX
1		28 g in 1 TUBE
2	NDC: 51141-0070-5	1 in 1 BOX
2		14 g in 1 TUBE
3	NDC: 51141-0070-3	1 in 1 BOX
3		9.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	09/01/2010

Labeler - NeoPharm Co., Ltd (631101883)

Registrant - NeoPharm Co., Ltd (631101883)

Establishment
Name	Address	ID/FEI	Business Operations
NeoPharm Co., Ltd		631101883	manufacture