Zostrix Diabetic Joint and Arthritis Pain Relief

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

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Zostrix Diabetic Joint and Arthritis Pain Relief Uses
• Warnings
  • When using this product
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• Directions
• Other Information
• Inactive ingredients
• Questions or Comments
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient

Capsaicin 0.025%

Menthol 2.0%

Purpose

Topical Analgesic

Topical Analgesic

Zostrix Diabetic Joint and Arthritis Pain Relief Uses

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

• strains
• sprains
• bruises
• arthritis

Warnings

For external use only.

Do not apply to wounds or to damaged or irritated skin.

When using this product

• 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.

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
• blistering occurs
• difficulty breathing or swallowing occurs
• severe burning persists

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
• to avoid getting cream on hands use applicator pad to apply a thin film of cream to the affected area and gently rub in until fully absorbed. Discard applicator pad after use.
• for optimum relief, apply 3 to 4 times daily
• best results typically occur after 2 to 4 weeks of continuous use
• unless treating hands, wash hands thoroughly with soap and water immediately after use
• see package insert for more information

Other Information

Store at 15°-30°C (59°-86°F).

Inactive ingredients

Benzyl Alcohol, Cetearyl Alcohol, Ceteareth-20, Cetyl Alcohol, Glyceryl Stearate, Isopropyl Myristate, PEG-100 Stearate, Petrolatum, Sorbitorl & 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.

Package/Label Principal Display Panel

Capsaicin 0.025%

Menthol 2.00%

NDC 61787-451-02

ZOSTRIX®

DIABETIC

Joint & Arthritis Pain Relief Cream

Topical Analgesic

Net Wt. 2 oz. (56.6g)

For best results, apply only a pea-sized amount regularly - up to 3-4 times daily.