FDA.reportPublic FDA data

Stopain Extra Strength Gel

Manufacturer
Troy Manufacturing, Inc.
Effective date
2026-04-16
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:54:27

Key Label Information#

Active Ingredients And Purpose

Active Ingredient

Menthol 8.0%

Uses

Uses

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

Warnings

Warnings

For external use only. Avoid contact with eyes Flammable: Keep away from fire or flame.

Directions And Dosage

Directions

Adults and children 2 years of age and older: • apply directly onto affected area, not more than 3 to 4 times daily • wash hands after use Children under 2 years of age: do not use, consult a doctor

Other Label Information

Inactive Ingredients

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).

Questions or comments?

1-800-201-7246

Package Labeling:473 mL

Package Labeling:946 mL

Label Images#

Label02
Label02
Label03
Label03
Bottle
Bottle
label
label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283257menthol 8 % Topical GelPSN8
1541592Stopain COLD 8 % Topical GelPSN8
1541592menthol 0.08 MG/MG Topical Gel [Stopain]SBD8
283257menthol 0.08 MG/MG Topical GelSCD8
283257menthol 8 % Topical GelSY8
1541592Stopain 0.08 MG/MG Topical GelSY8
1541592Stopain 8 % Topical GelSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63936-8800-1Stopain Extra Strength Gel3785 mL in 1 BOTTLEGEL37858
63936-8800-2Stopain Extra Strength Gel946 mL in 1 BOTTLEGEL9468
63936-8800-3Stopain Extra Strength Gel473 mL in 1 BOTTLEGEL4738
63936-8800-4Stopain Extra Strength Gel88 mL in 1 TUBEGEL888

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63936-880063936-8800-3, 63936-8800-2, 63936-8800-1, 63936-8800-4

Ingredients#

Name, UNII, Kind table
NameUNIIKind
ACRYLIC ACIDJ94PBK7X8SIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
EUCALYPTUS OIL2R04ONI662IACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
PENTYLENE GLYCOL50C1307PZGIACT
PEPPERMINT OILAV092KU4JHIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

Complete SPL Sections#

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 8.0%

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 Flammable: Keep away from fire or flame.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: • apply directly onto affected area, not more than 3 to 4 times daily • wash hands after use Children under 2 years of age: do not use, consult a doctor

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).

Questions or comments?

OTC - QUESTIONS SECTION

1-800-201-7246

Package Labeling:473 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Labeling:946 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Labeling:63936-8800-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Labeling:63936-8800-4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-12-09monthly-update2026-06-03 17:45:40