MYORX LOW DOSE PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]

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MYORX LOW DOSE PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]
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NDC 59088-954-05
Set ID 1c8f98c8-f1bf-4489-bfd4-8ae3a35c2127
Category HUMAN OTC DRUG LABEL
Packager PureTek Corporation
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active ingredient

    Menthol  0.5%

  • Purpose

    Topical Analgesic

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

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

  • Warnings

    For external use only.

    Do not

    • apply on wounds or damaged skin
    • bandage tightly

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
  • Directions

    Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

    Children under 2 years of age: consult a doctor.

  • Inactive ingredients

    Aloe Barbadensis (Aloe Vera) Leaf Juice, Borago Officinalis Seed Oil, Capsaicin, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Eucalyptus Globulus Leaf Oil, Fructose, Menhaden Oil, Methyl Salicylate, Methylparaben, Phenoxyethanol, Propylene Glycol, Propylparaben, Purified Water, Squalane, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Triethanolamine, Vitis Vinifera (Grape) Seed Oil.

  • STORAGE AND HANDLING

    Store at controlled room temperature 59°-86°F (15°-30°C).

  • Label

    image of label

  • INGREDIENTS AND APPEARANCE
    MYORX  LOW DOSE PAIN RELIEVING
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-954
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 uL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BORAGE OIL (UNII: F8XAG1755S)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    CARBOMER 934 (UNII: Z135WT9208)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    HYDROGENATED MENHADEN OIL (UNII: 736VD7888J)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SQUALANE (UNII: GW89575KF9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-954-0559 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2011
    Labeler - PureTek Corporation (785961046)
    Establishment
    NameAddressID/FEIBusiness Operations
    PureTek Corporation785961046manufacture, label, pack, outsourcing human drug compounding, relabel, repack
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