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

Western Family by

Drug Labeling and Warnings

Western Family by is a Otc medication manufactured, distributed, or labeled by Western Family Foods Inc, Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

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

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

Labeler - Western Family Foods Inc (192166072)

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

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