FDA.reportPublic FDA data

Stopain Clinical Spray

Manufacturer
Troy Manufacturing, Inc.
Effective date
2023-10-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:25:04

Label at a glance#

ProductStopain Clinical
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure8 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: ​apply directly onto affected area without the need to rub, massage or bandage repeat if necessary, but do not apply more than 4 times daily. ​Children 12 years or younger: ​ ​ask a doctor.

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

For external use only. Avoid contact with eyes.

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:

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

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Package labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63936-950063936-9500-1

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
EUCALYPTUS OIL2R04ONI662IACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
GLYCERINPDC6A3C0OXIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
PENTYLENE GLYCOL50C1307PZGIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
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
06ea3d35-67db-d0b8-e063-6294a90a5b0c3dc5aabe-818e-4fa2-bba1-b039724371192023-10-04WarningsExact identifier
spl id: 06ea3d35-67db-d0b8-e063-6294a90a5b0c
spl set id: 3dc5aabe-818e-4fa2-bba1-b03972437119

Reported adverse events (FAERS/openFDA)#

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