Western Family Triple Antibiotic Plus Pain Relief: Package Insert and Label Information

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bacitracin zinc (Bacitracin) Bacitracin 500 [iU] in 1 g Neomycin sulfate (Neomycin) Neomycin 3.5 mg in 1 g Polymyxin B sulfate (Polymyxin B) Polymyxin B 10000 [iU] in 1 g Pramoxine hydrochloride (Pramoxine) Pramoxine hydrochloride 10 mg in 1 g

Inactive Ingredients Ingredient Name Strength petrolatum

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55312-504-02 1 TUBE in 1 CARTON contains a TUBE 1 28 g in 1 TUBE This package is contained within the CARTON (55312-504-02)

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	Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE (55312-504)

Revised: 03/2013 Western Family Foods Inc