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| Product NDC Code | 61787-443 | ||||
|---|---|---|---|---|---|
| Drug Name | Zostrix hp |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part348 | ||||
| Labeler Name | MEDTECH PRODUCTS INC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Total Capsaicin 0.1%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For the temporary relief of minor aches and pains of muscles and joints associated with • arthritis • simple backache • strains • sprains
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.ZOSTRIX HP Capsaicin CAPSAICIN CAPSAICIN BENZYL ALCOHOL CETYL ALCOHOL GLYCERYL MONOSTEARATE ISOPROPYL MYRISTATE PEG-100 STEARATE WATER SORBITOL PETROLATUM ANHYDROUS CITRIC ACID
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL 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) PRINCIPAL DISPLAY PANEL 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)
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.ZOSTRIX HP- capsaicin cream Medtech Products Inc., a Prestige Consumer Healthcare company 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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep Out of Reach of Children If swallowed, get medical help or contact a Poison Control Center immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at 15° - 30°C (59° - 86°F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.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
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API