FDA.reportPublic FDA data

DPHEAL SUL 16 COOL

Manufacturer
MSMINERAL CO.,Ltd. | DONG IL PHARMS CO., LTD.
Effective date
2021-11-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:45:07

Label at a glance#

ProductDPHEAL SUL 16 COOL
Active ingredientMENTHOL, DIMETHYL SULFONE
Label structure12 sections

Indications and uses

■ Provides support for joint and cartilage health.

Dosage and administration

■ Before and after exercise, apply the appropriate amount to the desired area and massage. (Waist, shoulder, arm, knee, ankle, calf, etc.) Be careful with your face or sensitive body parts.When used by children, adult supervision is required.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Menthol 3.65%
Methyl Sulfonyl Methane(MSM) 10%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Purified water, Butylene Glycol, Ethylalcohol, Shea Butter, Lanoline oil, Caprylic/Capric Triglyceride, Sunflower Seed Oil, Tocopheryl Acetate, Hexandediol, Arginine, Carbomer, PEG-60 Hydrogenated Castor Oil, N-acetylglucosamine, Guaiazulene, Salix Alba (Willow) Bark Extract, Origanum Vulgare Leaf Extract, Scutellaria Baicalensis Root Extract, Chamaecyparis Obtusa Leaf Extract, Cinnamomum Cassia Bark Extract, Portulaca Oleracea Extract, Mineral water, Lactobacillus/Soybean Ferment Extract

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

■ Provides support for joint and cartilage health.

WARNINGS

WARNINGS SECTION

■ For external use only
■ When using cosmetics or immediately after use, if there are abnormal symptoms or side effects such as red spots, swelling, or itching due to direct sunlight, consult a specialist.
■ Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Directions

DOSAGE & ADMINISTRATION SECTION

■ Before and after exercise, apply the appropriate amount to the desired area and massage.
(Waist, shoulder, arm, knee, ankle, calf, etc.) Be careful with your face or sensitive body parts.When used by children, adult supervision is required.

Other Information

OTHER SAFETY INFORMATION

■ Store in a cool dry place with lid closed tightly

Questions

OTC - QUESTIONS SECTION

■ Customer service center : 1-770-878-3322
■ Homepage : www.msmmineral.com

DPHEAL SUL 16 COOL 120mLNDC: 82409-010-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of tubeImage of tube

DPHEAL SUL 16 COOL 100mLNDC: 82409-010-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of tubeImage of tube

DPHEAL SUL 16 COOL 50mLNDC: 82409-010-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of containerImage of container

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82409-010-012024-01-30C16284748780-11030e365-09ca-111a-e063-dadaa90a10e2113f6421-ebfc-41c0-ac56-19bc907aca6f
82409-010-022024-01-30C16284748780-11030e365-09ca-111a-e063-dadaa90a10e2113f6421-ebfc-41c0-ac56-19bc907aca6f
82409-010-032024-01-30C16284748780-11030e365-09ca-111a-e063-dadaa90a10e2113f6421-ebfc-41c0-ac56-19bc907aca6f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82409-010-01DPHEAL SUL 16 COOL120 mL in 1 TUBEGEL1201
82409-010-02DPHEAL SUL 16 COOL100 mL in 1 TUBEGEL1001
82409-010-03DPHEAL SUL 16 COOL50 mL in 1 CONTAINERGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82409-010DPHEAL SUL 16 COOL (MENTHOL, METHYLSULFONYLMETHANE) GEL [MSMINERAL CO.,LTD.]1Legacy NDC, 3 package rows20211127_113f6421-ebfc-41c0-ac56-19bc907aca6f.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82409-01082409-010-01, 82409-010-02, 82409-010-03

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
DIMETHYL SULFONE9H4PO4Z4FTACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT
ALCOHOL3K9958V90MIACT

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
eade9ee4-5c58-4f25-9a1e-7ba3f55511e7113f6421-ebfc-41c0-ac56-19bc907aca6f2021-11-26WarningsExact identifier
spl id: eade9ee4-5c58-4f25-9a1e-7ba3f55511e7
spl set id: 113f6421-ebfc-41c0-ac56-19bc907aca6f

Reported adverse events (FAERS/openFDA)#

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