Otc - Purpose
Topical analgesic
Capsadyn Cream
FDA Label NDC 83009-169
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chorda Pharma, Inc for the product Capsadyn (NDC 83009-169). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Capsaicin 0.25% as Capsaicin palmitate
Indications & Usage
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.
Warnings
For external use only.
Do not apply to wounds and damaged skin.
When using this product 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.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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
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.
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