DPHEAL SUL 16 COOL- menthol, methylsulfonylmethane gel

DPHEAL SUL 16 COOL by

Drug Labeling and Warnings

DPHEAL SUL 16 COOL by is a Otc medication manufactured, distributed, or labeled by MSMINERAL CO.,Ltd., DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 120mLNDC:

82409-010-01

DPHEAL SUL 16 COOL 100mLNDC:

82409-010-02

DPHEAL SUL 16 COOL 50mLNDC:

82409-010-03

INGREDIENTS AND APPEARANCE

DPHEAL SUL 16 COOL 
menthol, methylsulfonylmethane gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82409-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.65 g  in 100 mL
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) (DIMETHYL SULFONE - UNII:9H4PO4Z4FT)	DIMETHYL SULFONE	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82409-010-01	120 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2021
2	NDC: 82409-010-02	100 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2021
3	NDC: 82409-010-03	50 mL in 1 CONTAINER; Type 0: Not a Combination Product	11/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/01/2021

Labeler - MSMINERAL CO.,Ltd. (695060085)

Registrant - MSMINERAL CO.,Ltd. (695060085)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(82409-010)