DUSEL COOL ARTHRITIS DEAD SEA SALT THERAPY (MENTHOL) CREAM [NANOVITA ONE LLC]

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DUSEL COOL ARTHRITIS DEAD SEA SALT THERAPY (MENTHOL) CREAM [NANOVITA ONE LLC]
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NDC 70656-744-01
Set ID 293ff2ff-57e2-4a9f-8614-0dece134c99b
Category HUMAN OTC DRUG LABEL
Packager Nanovita One LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts:

  • Active Ingredient:

    Menthol 5.00%

    Topical Analgesic

  • Indications:

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

  • Warnings:

    • For external use only.
    • Avoid contact with eyes.
    • If symptoms persist for more than seven days, discontinue use and consult physician

    Keep out of reach of children.

    If swallowed, consult physician.

    Do not apply

    • to wounds or damaged skin.
    • Do not bandage tightly.

    If pregnant or breast feeding,

    • contact physician prior to use.

  • Directions:

    •Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
    •Children under two-years of age: consult a physician.

  • Additional Information:

    Store at room temperature.

  • Other Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Ethylhexylglycerin, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Oil, Ilex Paraguayensis (Yerba Mate’) Extract, C13-14 Isoparaffin, Isopropyl Alcohol, Isopropyl Myristate, Maris Sal (Dead Sea) Salt, Phenoxyethanol, Laureth-7, Polyacrylamide, Stearic Acid.

  • Package Labeling:

    cool 5ml

  • INGREDIENTS AND APPEARANCE
    DUSEL COOL ARTHRITIS DEAD SEA SALT THERAPY 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70656-744
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LAURETH-7 (UNII: Z95S6G8201)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70656-744-015 mL in 1 PACKET; Type 0: Not a Combination Product04/26/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/26/2016
    Labeler - Nanovita One LLC (080217774)
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