Capsimide Patch

Manufacturer
Sola Pharmaceuticals
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:20:44

Label at a glance#

ProductCapsimide
Active ingredientCAPSAICIN
Label structure14 sections

Indications and uses

Temporarily relieves minor pain.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.025%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep our of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Other Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

Capsimide pouchCapsimide pouch

Capsimide boxCapsimide box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043399capsaicin 0.025 % Medicated PatchPSN4
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD4
1043399capsaicin 0.025 % Medicated PatchSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130070512016103GTIN-13: 0070512016103
EAN-13: 0070512016103
GTIN-12: 070512016103
UPC-A: 070512016103
GTIN storage (14 digits): 00070512016103
Capsimide patch box.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70512-016-10Capsimide10 in 1 BOXPATCH104
70512-016-10Capsimide9 g in 1 POUCHPATCH94

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-016-10EA - Each70512-016566629ed-4be0-4a05-8d26-531226f2bb4f12022-11-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70512-01670512-016-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CapsimideCAPSAICIN 0.025% TOPICAL PATCHSola Pharmaceuticalse81c2de8-6429-d681-e053-2995a90a36a92025-12-08WarningsExact identifier
ndc (package): 70512-016-10
ndc (product): 70512-016
ndc11 (package): 70512001610
spl id: 45724ae3-b3d0-638d-e063-6294a90af2da
spl set id: e81c2de8-6429-d681-e053-2995a90a36a9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.