WORKVIE (LIDOCAINE, MENTHOL) CREAM [MARKETITES LLC]

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WORKVIE (LIDOCAINE, MENTHOL) CREAM [MARKETITES LLC]
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NDC 72393-202-25
Set ID 857f3783-6f42-3bac-e053-2a91aa0af849
Category HUMAN OTC DRUG LABEL
Packager Marketites LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • ACTIVE INGREDIENT

    Active Ingredients

    Lidocaine HCL 4% w/w

    Menthol 1% w/w

  • PURPOSE

    Purpose

    Topical analgesic

    Topical analgesic

  • INDICATIONS & USAGE

    USES For temporary relief of pain.

  • WARNINGS

    Warnings

    For external use only. Avoid contact with eyes.

    Do not use in large quantities, particularly over raw surfaces, or blistered areas.

    Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

    If pregnant or breast feeding, ask a health professional.

  • DOSAGE & ADMINISTRATION

    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.

  • OTHER SAFETY INFORMATION

    Other Information

    store in a cool dry place between (59-86°F) 15-30°C

    don't use if seal over cap is broken, torn or missing

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Arnica Extract, Caprylyl Glycol, Capsicum Annuum Fruit Extract, Chamomile Extract, Devil’s Claw Extract, Dimethicone, Dimethyl Sulfone (MSM), Eucalyptus Oil, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycol Stearate, Horse Chestnut Extract, Isopropyl Myristate, Lemon Balm Extract, Linden Flower Extract, Menthyl Lactate, PEG-100 Stearate, Phenoxyethanol, Rosemary Extract, Sweet Almond Oil, Triethanolamine, Water, Willow Bark Extract

  • QUESTIONS

    Questions or comments

    info@workvie.com

  • PRINCIPAL DISPLAY PANEL

    Workvie Lidocaine Roll On Label

  • INGREDIENTS AND APPEARANCE
    WORKVIE 
    lidocaine, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72393-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PAPRIKA (UNII: X72Z47861V)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LEMON BALM OIL (UNII: MJ76269K9S)  
    LINDEN LEAF (UNII: RU6O456OJ1)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SALIX NIGRA BARK (UNII: QU52J3A5B3)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72393-202-2571 g in 1 BOTTLE, WITH APPLICATOR; 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 - Marketites LLC (036140212)
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