MINTED LEAF COLD THERAPY PAIN RELIEF ROLL-ON (MENTHOL) SOLUTION [MMG CONSUMER BRANDS, LLC]

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MINTED LEAF COLD THERAPY PAIN RELIEF ROLL-ON (MENTHOL) SOLUTION [MMG CONSUMER BRANDS, LLC]
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NDC 73102-116-03
Set ID ddd86239-fe04-4123-a8aa-42afd6ab4952
Category HUMAN OTC DRUG LABEL
Packager MMG Consumer Brands, LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts

  • Active Ingredient:

    Menthol 4.00%

    Purpose

    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 physcian.
  • Additional Information:

    Store at room temperature.

  • Other Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arcticum Lappa (Burdock) Root Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Camellia Sinensis (Green Tea) Extract, Cannabis Sativa (Broad Spectrum Hemp) Oil, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Ilex Paraguariensis (Yerba Mate’) Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Extract, Methylsulfonylmethane (MSM), Phenoxyethanol, Sorbitan Olivate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

  • Package Labeling:

    Label4

  • INGREDIENTS AND APPEARANCE
    MINTED LEAF COLD THERAPY PAIN RELIEF ROLL-ON 
    menthol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73102-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MELISSA OFFICINALIS (UNII: YF70189L0N)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73102-116-0388 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2019
    Labeler - MMG Consumer Brands, LLC (117036455)
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