Solstice Capsaicin Patch Hot

Manufacturer
MADISON ONE ACME INC | Foshan Aqua Gel Biotech Co., Ltd.,
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:43:14

Label at a glance#

ProductSolstice Capsaicin Patch Hot
Active ingredientCAPSAICIN
Label structure16 sections

Storage and handling

Other information keep patches tightly closed in the zip-lock pouch avoid excessive heat

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Capsaicin 0.025%

OTC - PURPOSE SECTION

Purpose
External analgesic

INDICATIONS & USAGE SECTION

Uses
For the temporary relief of minor aches and pains of muscles and joints due to:
simple backache
arthritis
strains
bruises
sprains

WARNINGS SECTION

Warnings
For external use only

OTC - DO NOT USE SECTION

Do not use
on irritated or damaged skin on wounds

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you have
any concerns about using this product

OTC - WHEN USING SECTION

When using this product
avoid contact with the eyes or mucous membranes

do not bandage tightly

do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)

avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch

OTC - STOP USE SECTION

Stop use and ask a doctor if
condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

excessive irritation of the skin develops

nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)

when using for pain of arthritis:
   pain persists for more than 10 days
   redness is present
   in conditions affecting children under 12 years of age

ADVERSE REACTIONS SECTION

Report any unexpected side effectsfrom the use of this product to the FDA MedWatch Program

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
adults and children 12 years of age and older:
   clean and dry affected area
   remove the protective film from the patch
   apply patch to affected area not more than 3 to 4 times daily
   remove patch from the skin after at most 8-hour application
   wet patch with warm water before removing from the skin

children under 12 years of age: consult your physician

STORAGE AND HANDLING SECTION

Other information
keep patches tightly closed in the zip-lock pouch
avoid excessive heat

INACTIVE INGREDIENT SECTION

Inactive ingredientshydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, and styrene/isoprene copolymer.

OTC - QUESTIONS SECTION

Questions or comments?(888) 221-3496 M-F 9 am to 5 pm
you may also report serious side effects to this phone number

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Solstice Capsaicin Patch Hot

Capsaicin 0.025%

NDC 55614-410-01

1 Patches, Each Patch 5.12 in x 7.09 in (13 cm x 18 cm)
IMAGE OF 1 PATCH POUCHIMAGE OF 1 PATCH POUCH

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Solstice Capsaicin Patch Hot

Capsaicin 0.025%

NDC 55614-410-03

3 Patches, Each Patch 5.12 in x 7.09 in (13 cm x 18 cm)
IMAGE OF 3 PATCH POUCHIMAGE OF 3 PATCH POUCH

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043399capsaicin 0.025 % Medicated PatchPSN6
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD6
1043399capsaicin 0.025 % Medicated PatchSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55614-410-01Solstice Capsaicin Patch Hot9 g in 1 PATCHPATCH96
55614-410-01Solstice Capsaicin Patch Hot1 in 1 POUCHPATCH16
55614-410-03Solstice Capsaicin Patch Hot9 g in 1 PATCHPATCH96
55614-410-03Solstice Capsaicin Patch Hot3 in 1 POUCHPATCH36

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55614-41055614-410-01, 55614-410-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-11-25full-release2026-06-01 00:39:32

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
Solstice Capsaicin Patch HotCAPSAICINMADISON ONE ACME INCf74db6e0-853a-4eb3-a4b5-9da2cd3d95cf2025-11-10Warnings, Adverse reactionsExact identifier
ndc (package): 55614-410-03
ndc (package): 55614-410-01
ndc (product): 55614-410
ndc11 (package): 55614041001
ndc11 (package): 55614041003
spl id: 43462d73-413b-48b9-e063-6294a90a9968
spl set id: f74db6e0-853a-4eb3-a4b5-9da2cd3d95cf

Reported adverse events (FAERS/openFDA)#

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