FDA Label for Zostrix Hp
View Indications, Usage & Precautions
Zostrix Hp Product Label
The following document was submitted to the FDA by the labeler of this product Medtech Products Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Total Capsaicin 0.1%
Purpose
Topical Analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with
• arthritis • simple backache • strains • sprains
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 diminishes.
• avoid contact with eyes. Do not get it on mucous membranes, into eyes, or on contract 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.
•apply a thin film of cream to the affected area and gently rub in until fully absorbed.
•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, cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, PEG-100 stearate, purified water, sorbitol solution & white petrolatum.
*May contain this ingredient to adjust pH.
Questions Or Comments?
Call: 1-800-579-8327
Serious side effects associated with the use of this product may be reported to this number.
Zostrix.com
Package/Label Principal Display Panel
NDC 61787-443-02
MAXIMUM STRENGTH
ZOSTRIX®
NATURAL PAIN RELIEF
Capsaicin 0.1% Topical Analgesic
BLOCKS YOUR BODY’S PAIN MESSENGER
ODOR FREE CREAM
WARMTH FROM CHILI PEPPERS
NET WT 2.0 OZ. (57 g)
* Please review the disclaimer below.