Cvs Triple Antibiotic (Bacitracin, Neomycin, Polymyxin B) Ointment [Cvs Pharmacy] -

CVS TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN, POLYMYXIN B) OINTMENT [CVS PHARMACY]
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NDC	69842-610-71
Set ID	454bfeed-f58f-003a-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	CVS Pharmacy
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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Drug Facts

Active Ingredients (in each gram)

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxin B 5,000 units
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

• in the eyes

• over large areas of the body

Ask a doctor before use if you have

• deep or puncture wounds • animal bites • serious burns

Stop use and ask a doctor if

• you need to use longer than 1 week

• condition persists or gets worse

• rash or other allergic reaction develops • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions

• clean the affected area • apply a small amount of 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
Inactive Ingredients

white petrolatum
Purpose

First Aid Antibiotic
Other information

•store at controlled room temperature

• prior to initial use, please prime pump by depressing multiple times
Questions or Comments?

1-800-635-3696
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS TRIPLE ANTIBIOTIC
bacitracin, neomycin, polymyxin b ointment

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-610-71	1 in 1 PACKAGE	11/01/2008
1		7.7 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	11/01/2008

Labeler - CVS Pharmacy (062312574)

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