FDA.reportPublic FDA data

Stopain Clinical Roll-On

Manufacturer
Troy Manufacturing, Inc.
Effective date
2025-07-21
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:08:05

Label at a glance#

ProductStopain Clinical Roll-On
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure11 sections

Indications and uses

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

Dosage and administration

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

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
  • strains
  • 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 if 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

​ ​Adults and children over 12 years:

​ask a doctor. ​Children 12 years or younger:

  • roll directly onto affected area without the need to rub, massage or bandage
  • repeat if necessary, but do not apply more than 4 times daily.

Other Information

SPL UNCLASSIFIED SECTION

  • Store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

boswellia serrata extract, carbomer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerine, PEG-8 dimethicone, pentylene glycol, peppermint oil, SD alcohol 39C, triethanolamine, water (USP)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259249menthol 10 % Topical GelPSN7
1865942Stopain CLINICAL 10 % Topical GelPSN7
1865942menthol 0.1 MG/MG Topical Gel [Stopain]SBD7
259249menthol 0.1 MG/MG Topical GelSCD7
259249menthol 10 % Topical GelSY7
1865942Stopain 0.1 MG/MG Topical GelSY7
1865942Stopain 10 % Topical GelSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63936-9520-1Stopain Clinical Roll-On88 mL in 1 BOTTLEGEL887

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63936-952063936-9520-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
INDIAN FRANKINCENSE4PW41QCO2MIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
EUCALYPTUS OIL2R04ONI662IACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
GLYCERINPDC6A3C0OXIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
PENTYLENE GLYCOL50C1307PZGIACT
PEPPERMINT OILAV092KU4JHIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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 Clinical Roll-OnMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.27703209-fdac-4620-a445-d89a84bc853d2025-07-21WarningsExact identifier
ndc (package): 63936-9520-1
ndc (product): 63936-9520
ndc11 (package): 63936952001
spl id: 3a7467f8-bd39-d826-e063-6294a90a13c5
spl set id: 27703209-fdac-4620-a445-d89a84bc853d

Reported adverse events (FAERS/openFDA)#

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