Western Family Triple Antibiotic Plus Pain Relief (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride) Ointment [Western Family Foods Inc] -

WESTERN FAMILY TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [WESTERN FAMILY FOODS INC]
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NDC	55312-504-02
Set ID	526f982e-cb51-4460-9c71-a1a5c6828a41
Category	HUMAN OTC DRUG LABEL
Packager	Western Family Foods Inc
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (each gram contains)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine hydrochloride 10 mg	Topical analgesic

Uses
first aid to help prevent infection and for the temporary relief of pain or discomfort in
- minor cuts
- scrapes
- burns
Warnings
For external use only
Do not use
- in the eyes
- over large areas of the body
- if you are allergic to any of the ingredients
- longer than 1 week
Ask a doctor before use
- on deep or puncture wounds, animal bites, or serious burns
Stop use and ask a doctor if
- condition gets worse
- condition persists for more than 7 days
- condition clears up and occurs again within a few days
- a 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 and older:
- 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
Children under 2 years of age: consult a doctor
Other information
- To open: unscrew cap, pull tab to remove foil seal
- store at room temperature
- see carton or tube crimp for lot number and expiration date
Inactive ingredient

white petrolatum
Questions?

Call 1-866-923-4914
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Distributed By:
Western Family Foods, Inc.
P.O. Box 4057, Portland, OR 97208
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Triple Antibiotic
(Bacitracin Zinc-Neomycin Sulfate
Polymyxin B Sulfate-Pramoxine HCL)
OINTMENT+ PAIN RELIEF

NET WT 1 OZ
(28g)

First Aid Antibiotic /Topical Pain Reliever

INGREDIENTS AND APPEARANCE

WESTERN FAMILY TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-504
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	500 [iU] 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	10000 [iU] in 1 g
Pramoxine hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine hydrochloride	10 mg in 1 g

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

#	Item Code	Package Description
Packaging
1	NDC:55312-504-02	1 in 1 CARTON
1		28 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333B	03/31/2012

Labeler - Western Family Foods Inc (192166072)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(55312-504)

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Medic

WESTERN FAMILY TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [WESTERN FAMILY FOODS INC]

Do not use

Ask a doctor before use

Stop use and ask a doctor if

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