DPHEAL SUL 16 COOL- menthol, methylsulfonylmethane gel 
MSMINERAL CO.,Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENTS

Menthol 3.65%
Methyl Sulfonyl Methane(MSM) 10%

INACTIVE INGREDIENTS

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

Topical Analgesic

Uses

■ Provides support for joint and cartilage health.

WARNINGS

■ 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

KEEP OUT OF REACH OF CHILDREN

Directions

■ 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

■ Store in a cool dry place with lid closed tightly

Questions

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

DPHEAL SUL 16 COOL 120mL
NDC: 82409-010-01

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DPHEAL SUL 16 COOL 100mL
NDC: 82409-010-02

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DPHEAL SUL 16 COOL 50mL
NDC: 82409-010-03

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DPHEAL SUL 16 COOL 
menthol, methylsulfonylmethane gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82409-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.65 g  in 100 mL
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) (DIMETHYL SULFONE - UNII:9H4PO4Z4FT) DIMETHYL SULFONE0.02 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82409-010-01120 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2021
2NDC:82409-010-02100 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2021
3NDC:82409-010-0350 mL in 1 CONTAINER; Type 0: Not a Combination Product11/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/01/2021
Labeler - MSMINERAL CO.,Ltd. (695060085)
Registrant - MSMINERAL CO.,Ltd. (695060085)
Establishment
NameAddressID/FEIBusiness Operations
DONG IL PHARMS CO., LTD.557810721manufacture(82409-010)

Revised: 11/2021
Document Id: eade9ee4-5c58-4f25-9a1e-7ba3f55511e7
Set id: 113f6421-ebfc-41c0-ac56-19bc907aca6f
Version: 1
Effective Time: 20211126
 
MSMINERAL CO.,Ltd.