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Product NDC Code | 72847-316 | ||||
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Drug Name | Capzix |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 646333 | ||||
Application Number | M017 | ||||
Labeler Name | Toprail Chp Llc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: 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 – Adults and children over 18 Apply to affected area not more than 3 to 4 times daily. If product comes in contact with hands, wash with soap and water. For children under 18 years of age ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water, Cetyl Alcohol, Petrolatum, Glyceryl Stearate, PEG-100 Stearate, Sorbitol, Isopropyl Myristate, Benzyl Alcohol, Citric Acid.
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: Provides penetrating pain relief. Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and 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.CAPZIX Capsaicin CAPSAICIN CAPSAICIN WATER CETYL ALCOHOL PETROLATUM GLYCERYL MONOSTEARATE PEG-100 MONOSTEARATE SORBITOL ISOPROPYL MYRISTATE BENZYL ALCOHOL CITRIC ACID MONOHYDRATE
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.Packaging label
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.High Potency Pain Relief For Arthritis, Sore Muscles, Joint and Back Pain Relief NDC# 72847-316-20 Distributed by: TopRail Medical Products Glencoe, IL www.toprailmedical.com Made in the USA
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other Information: STORE TIGHTLY CLOSED, IN A COOL DRY PLACE
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. Avoid contact with eyes. Do not apply to wounds or damaged skin. Do not bandage tightly or apply local heat (such as heating pads) to the area of use. Stop use and ask 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. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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