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Capsadyn - Medication Information

Product NDC Code 83009-169
Drug Name

Capsadyn

Type Brand
Active Ingredients
Capsaicin .25 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 199078
Application Number M017
Labeler Name Chorda Pharma, Inc
Packages
Package NDC Code Description
83009-169-01 28 g in 1 jar (83009-169-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Capsaicin 0.25% as Capsaicin palmitate

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.
Adults and children 18 years of age and older: apply to affected areas not more than 3-4 times daily, rub in the cream until completely absorbed, the amount used depends on the depth of the pain, typically provides pain relief without any noticeable warming or cooling, wash hands thoroughly with soap and water after applying. Children under 18 years of age: consult a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Butyrospermum parkii (shea) butter, ceteareth-20, cetyl alcohol, cocos nucifera (coconut) oil, ethylhexylglycerin, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, myristyl myristate, phenoxyethanol, polysorbate 20, stearic acid, water.

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.
For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, muscle strains, sprains, bruises, related muscle injuries, and simple backache. Provides penetrating pain relief.

Purpose

Information about the drug product’s indications for use.
Topical analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
Capsadyn Capsaicin POLYSORBATE 80 PHENOXYETHANOL STEARIC ACID COCONUT OIL ETHYLHEXYLGLYCERIN GLYCERYL MONOSTEARATE POLYOXYL 20 CETOSTEARYL ETHER GLYCERIN WATER CAPSAICIN CAPSAICIN MYRISTYL MYRISTATE SHEA BUTTER SUNFLOWER OIL

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.
Carton

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.
If swallowed, get medical help or contact a Poison Control Center right away.

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.
For external use only. Do not apply to wounds and damaged skin. When using this produc t use only as directed, temporary warming of skin may be experienced after application, avoid contact with eyes or mucous membranes, do not bandage tightly, do not expose the treated area to heat, and avoid activity that may cause perspiration. 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.

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