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| Product NDC Code | 50268-197 | ||||
|---|---|---|---|---|---|
| Drug Name | Capsaicin |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 646333 | ||||
| Application Number | M017 | ||||
| Labeler Name | AvPAK | ||||
| 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: 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 18 years of age and older apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands, wash hands thoroughly with soap and water immediately after application for best results, apply 3 to 4 times daily Children under 18 years: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum
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.Capsaicin Capsaicin WATER CETYL ALCOHOL PETROLATUM PEPPERMINT OIL PEG-100 STEARATE PHENOXYETHANOL CAPSAICIN CAPSAICIN GLYCERYL STEARATE SE XANTHAN GUM MINERAL OIL ALOE VERA LEAF STEARYL ALCOHOL PROPYLENE GLYCOL
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 56
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.Questions? Comments? 1-855-361-3993 Manufactured for: AvKARE, Pulaski, TN 38478 www.avkare.com AV 06/22
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 at room temperature 15° - 30°C (59° - 86°F)
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 use: on wounds or damaged skin if you are allergic to capsicum or chili peppers with heating pad When using this produce: you may experience a burning sensation The intensity of this reaction varies among individuals and may be severe. With regular use, the sensation generally disappears after several days. avoid contact with the eyes, lips, nose and mucous membranes do not tightly wrap or bandage the treatement area do not apply heat, or direct sunlight to the treated area immediately before or after use Stop use and ask a doctor if: condition worsens or does not improve after regular use severe burning persists redness or blistering occurs 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