Active Ingredients
Capsaicin 0.025%
Capsimide Patch
FDA Label NDC 70512-016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sola Pharmaceuticals for the product Capsimide (NDC 70512-016). 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 ingredients, 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
Topical Analgesic
Uses
Temporarily relieves minor pain.
Warnings
For external use only
Do Not Use
- more than one patch on your body at a time
- on cut, irritated or swollen skin
- on puncture wounds
- for more than one week without consulting a doctor
- if you are allergic to any active or inactive ingredients
- if pouch is damaged or opened
When Using This Product
- use only as directed
- read and follow all directions and warnings on this carton
- do not allow contact with the eyes
- do not sue at the same time as other topical analgesics
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
- do not microwave
- dispose of used patch in a manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Stop Use And Ask A Doctor If
- condition worsens
- redness is present
- irritation develops
- symptoms persist for more than 7 days or clear up and occur again within a few days
- you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Our Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and over: Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use. Children under 12 years of age: consuly a physician.
Other Information
Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.
Other Ingredients
Glycerin, Sodium polyacrylate, Dihydroxyaluminum aminoacetate, Edetate disodium, Kaolin, Carboxymethylcellulose sodium, Titanium dioxide, L-Tartaric acid, Polyacrylic acid, Propylene glycol, Polysorbate 80, Isopropyl Myristate, Hydroxyacetophenone, Water, and PVP
Questions Or Comments?
866-747-7365
Package Label.Principal Display Panel
Manufactured for:
SOLA PHARMACEUTICALS LLC
Baton Rouge, LA 70810
www.solameds.us
Made in China
Capsimide Patch
NDC 70512-016-10
Qty: 10 Patches
(1 per pouch) x 10
* Please review the disclaimer below.
