PURE INFLAMEDIX NATURAL PAIN RELIEF (MENTHOL) CREAM [NUTRAGEN HEALTH INNOVATIONS, INC.]

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PURE INFLAMEDIX NATURAL PAIN RELIEF (MENTHOL) CREAM [NUTRAGEN HEALTH INNOVATIONS, INC.]
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NDC 72016-140-03
Set ID 88307acf-371c-4b98-be14-949bd1ab33d6
Category HUMAN OTC DRUG LABEL
Packager Nutragen Health Innovations, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts

  • Active ingredient

    Menthol 3.00%

    Purpose

    Topical Analgesic

  • Uses

    temporary relief of minor aches and pains of the muscles and joints associated with:

    - arthritis    - simple backache   - sprains    - bruises    - strains

  • ​Warnings

    ​For external use only.

    • avoid contact with eyes.
    • if symptoms persist for more than seven days, discontinue use and consult a physician.

    • do not apply to wounds, damaged or open skin.
    • do not bandage tightly

    If pregnat or breast-feeding,

    ask a healthcare professional before use.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center immediately (800)222-1222

  • Directions

    • use only as directed
    • 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
  • ​Other information

    • Store at room temperature
  • ​Inactive ingredients

    Organic Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Organic Arnica Montana Flower Extract, Organic Boswellia Carteria (Frankincense) Oil, Ceteryl Olivate, Organic Curcuma Longa (Turmeric) Oil, Emul Oil, Organic Eucalyptus Globulus Oil, Glycerin, Glyceryl Caprylate, Glyceryl stearate, Glyceryl Undecylenate, Organic Hellanthus Annuus (Sunflower) Oil, Methylsulfonylmethana (MSM), Sorbitan Olivate, Organic Symphytum Officinale (Comfrey) Extract, Xanthan Gum, Organic Zingiber Officinale (Ginger) Root Oil.

  • ​Questions?

    call toll free 877-417-PURE (7873)

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    PURE INFLAMEDIX NATURAL PAIN RELIEF 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72016-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    TURMERIC OIL (UNII: 6KGS8SP16U)  
    EMU OIL (UNII: 344821WD61)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72016-140-031 in 1 CARTON01/10/2018
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/10/2018
    Labeler - Nutragen Health Innovations, Inc. (041739410)
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