Zostrix Hot and Cold Therapy System

Health Care Products
Hi-Tech Pharmacal Co., Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient in Hot Therapy
• Active ingredient in Cold Therapy
• Purpose
• Zostrix Hot and Cold Therapy System Uses
• Warnings
  • When using Hot Therapy
  • When using Cold Therapy
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• Directions
• Zostrix Hot and Cold Therapy System Other information
• Inactive ingredients in Hot Therapy
• Inactive ingredients in Cold Therapy
• Questions or Comments?
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient in Hot Therapy

Capsaicin 0.025%

Active ingredient in Cold Therapy

Menthol 4%

Purpose

Topical Analgesic

Zostrix Hot and Cold Therapy System Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only

Do not apply to wounds or to damaged or irritated skin

When using Hot Therapy

• you may experience a burning sensation which is normal and related to the way the product works. With regular use, this sensation generally disappears within several days.
• avoid contact with eyes. Do not get it on mucous membranes, into eyes or on contact lenses. If this occurs, rinse the affected area thoroughly with water.
• do not apply immediately before or after activities such as bathing, swimming, sun bathing, or strenuous exercise
• do not apply heat to the treated areas immediately before or after use
• do not tightly wrap or bandage the treated area
• avoid inhaling airborne material from dried residue. This can result in coughing, sneezing, tearing, throat or respiratory irritation.

When using Cold Therapy

• you may experience a cooling sensation which is normal and is related to the way the product works
• avoid contact with eyes. Do not get it on mucous membranes, into eyes, or on contact lenses. If this occurs, rinse the affected area thoroughly with water.
• do not apply heat to the treated areas immediately before or after use
• do not tightly wrap or bandage the treated area

Stop use and ask a doctor if

• condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor
• blistering occurs
• difficulty breathing or swallowing occurs (Hot Therapy)
• severe burning persists (Hot Therapy)
• redness or irritation develops (Cold Therapy)

Keep out of reach of children.

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

Directions

• for persons under 18 years of age, ask a doctor before using
• apply a thin film of cream and gently rub in until fully absorbed
• for optimum relief, apply 3 to 4 times daily
• best results occur after 2 to 4 weeks of continuous use
• wash hands thoroughly with soap and water immediately after use

Directions: For Alternating Therapy

For persons under 18 years of age, ask a doctor before using. Adults and persons 18 years of age an older: Start by applying the Cold Therapy to the affected area, then switch to the Hot Therapy and then back to the Cold Therapy and then to the Hot Therapy, using each therapy no more than 3 to 4 times per day. Best results typically occur after 2 to 4 weeks of continuous use. Wash hands thoroughly with soap and water immediately after use. See package insert for more information.

Zostrix Hot and Cold Therapy System Other information

• tamper evident: Do not use if seal at mouth of tube is missing or broken
• store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients in Hot Therapy

Benzyl Alcohol, Cetyl Alcohol, Glyceryl Stearate, Isopropyl Myristate, PEG-100 Stearate, Purified Water, Sorbitol Solution, White Petrolatum

Inactive ingredients in Cold Therapy

Benzyl Alcohol, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Glyceryl Stearate, Isopropyl Myristate, PEG-100 Stearate, Petrolatum, Sorbitol, Water

Questions or Comments?

Call: 1-800-899-3116, Mon. - Thurs. 9:00 am - 5:00 pm EST, Fri. 9:00 am - 2:30 pm EST. Serious side effects associated with the use of this product may be reported to this number.

Rev #499:01 7/12

Package/Label Principal Display Panel

NEW!

NDC 61787-499-02

ZOSTRIX®

HOT & COLD

THERAPY SYSTEM

Breakthrough Pain Relief!

The Power of 2 Alternating Therapies Relieves Pain Like No Other!

Back Aches • Arthritis • Bursitis

Body Aches • Sore Muscles • Sprains

Capsaicin 0.025% Hot Therapy Cream Net Wt. 1 oz. (28.3 g)

Menthol 4.0% Cold Therapy Cream Net. Wt. 1 oz. (28.3 g)

Topical Analgesic