Label: DPHEAL SUL 16 COOL- menthol, methylsulfonylmethane gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 26, 2021

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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 120mLNDC: 82409-010-01

    Image of tube

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

    Image of tube

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

    Image of container

  • INGREDIENTS AND APPEARANCE
    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)
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