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| Product NDC Code | 69396-103 | ||||
|---|---|---|---|---|---|
| Drug Name | Capsaicin cream |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 646333 | ||||
| Application Number | part348 | ||||
| Labeler Name | Trifecta Pharmaceuticals USA LLC | ||||
| 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 over 18 years: Apply to affected area Massage into the painful area until thoroughly absorbed Repeat as necessary but not more than 3 to 4 times daily WASH HANDS WITH SOAP AND WATER AFTER APPLYING Children 18 years and younger: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe barbadensis leaf juice, Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Purified Water, Polyoxyethylene Lauryl Ether, Stearic 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 For the temporary relief of minor aches and pains of muscles and joints associated with: Arthritis Simple Backache Strains Sprains Bruises
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 Cream Capsaicin LAURETH-23 STEARIC ACID CETOSTEARYL ALCOHOL CAPSAICIN CAPSAICIN ALOE VERA LEAF ETHYLPARABEN MINERAL OIL WATER GLYCERIN GLYCERYL MONOSTEARATE PETROLATUM
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.globe-capsaicin-60g-CDER
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.Drug Facts
Other Information Distributed by Trifecta Pharmaceuticals USA 101 NE Third Aveue, Suite 1500 Fort Lauderdale, FL 33301 www.trifecta-pharma.com
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 the Reach of Children If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions Questions or Comments Please call Toll Free 1-888-296-9067
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 Doctor Stope Use and Ask Doctor if: Condition worsens Symptoms persist for more than 7 days or clear up and occur again within a few days Redness is present irritation develops You experience signs of skin injury such as pain, swelling or blistering.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf Pregnant or Breast Feeding Ask a doctor before use
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at room temperature 15°-30°F (59°-86°F) This product is not manufactured or distributed by Chattem, distributor of Capzaicin-HP arthritis pain relief.
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: TEST FIRST ON SMALL AREA OF SKIN. When using this product: Use only as directed Do not apply to wounds, damaged, broken or irritated skin Avoid contact with the eyes or mucous membranes A slight burning sensation may occur upon application, but generally disappears after several days If severe burning occurs, discontinue use Do not expose the treated area to heat or direct sunlight Do not bandage Do not use with heating pad Do not use at the same time as other topical analgesics
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