FDA.reportPublic FDA data

Stopain Clinical

Manufacturer
Troy Manufacturing, Inc.
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:57:32

Label at a glance#

ProductStopain Clinical
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • stains • bruises • sprains

Dosage and administration

• apply directly onto affected area without the need to bandage • repeat if necessary, but do not apply more than 4 times daily. Adults and children over 12 years:  ask a doctor. Children 12 years of younger:

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10.0%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • stains • bruises • sprains

Warnings

WARNINGS SECTION

Avoid contact with eyes. For external use only.

Flammable: Keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

• use only as directed • do not bandage tightly or use a heating pad • do not apply to wounds or damaged skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • excessive irritation of the skin develops

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out 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

• apply directly onto affected area without the need to bandage • repeat if necessary, but do not apply more than 4 times daily. Adults and children over 12 years: 

ask a doctor. Children 12 years of younger:

Other Information

SPL UNCLASSIFIED SECTION

• Store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, hydroxypropylcellulose, PEG-8 dimethicone, pentylene glycol, peppermint oil, SD alcohol 39C, triethanolamine, water (USP).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label02Label02Label3Label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259249menthol 10 % Topical GelPSN3
1865942Stopain CLINICAL 10 % Topical GelPSN3
1865942menthol 0.1 MG/MG Topical Gel [Stopain]SBD3
259249menthol 0.1 MG/MG Topical GelSCD3
259249menthol 10 % Topical GelSY3
1865942Stopain 0.1 MG/MG Topical GelSY3
1865942Stopain 10 % Topical GelSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63936-9751-1Stopain Clinical12 in 1 BOXGEL123
63936-9751-1Stopain Clinical3 g in 1 PACKETGEL33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63936-9751STOPAIN CLINICAL (MENTHOL) GEL [TROY MANUFACTURING, INC.]3Current NDC, 2 package rows20231025_3336cc35-e773-4705-84b5-61040604beef.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63936-975163936-9751-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHYL SULFONE9H4PO4Z4FTIACT
EUCALYPTUS OIL2R04ONI662IACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
PENTYLENE GLYCOL50C1307PZGIACT
PEPPERMINT OILAV092KU4JHIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

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
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.3336cc35-e773-4705-84b5-61040604beef2023-10-25WarningsExact identifier
ndc (package): 63936-9751-1
ndc (product): 63936-9751
ndc11 (package): 63936975101
spl id: 0885415f-b01d-4dd2-e063-6294a90ac5ac
spl set id: 3336cc35-e773-4705-84b5-61040604beef

Reported adverse events (FAERS/openFDA)#

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