Active Ingredient
Capsaicin 0.025% w/w
Capsaicin 0.025% Patch
FDA Label NDC 85096-401
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marcella Health for the product Capsaicin 0.025% (NDC 85096-401). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Uses
For temporary relief of minor aches & pains of muscles & joints associated with:
- simple backache
- arthritis
- stratins
- bruises
- sprains
Warnings
For external use only
Do Not Use
- On wounds or damaged skin
- With a heating pad
- If you are allergic to any ingredients of this product
When Using This Product
- Use only as directed
- Avoid contact with the eyes, mucous membranes or rashes
- Do not bandage tightly
Stop Use And Ask A Doctor If
- Rash, itching or excessive skin irratation develops
- Condition worsen
- Symptoms persist for more than 7 days
- Symptoms clear up and occur again within a few days
If Pregnant Or Breast-Feeding,
Ask a health professional before use
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away
Directions
Adult and Children 12 years of age and over:
- Clean and dry affected area
- Remove film from patch and apply to the skin
- Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
- Remove patch from the skin after at most 8-hour application
Children under 12 years of age:Consult a doctor
Other Information
- Avoid storing product in direct sunlight
- Protect product from excessive moisture
Inactive Ingredients
Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Isopropyl Myristate, Polysorbate 80, PVP, Hydroxyacetophenone, Dihydroxyaluminum Aminoacetate, L-Tartaric Acid, Titanium Dioxide, Carboxymethylcellulose Sodium, Kaolin, Edetate Disodium.
Questions Or Comments
Call toll free (307) 410-3813 or [email protected]
Drug Facts
Pouch:
#30 Box
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