Label: GOUT RELIEVER SYNERGY oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 24, 2016

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  • ACTIVE INGREDIENT

    Drug facts

    Methyl salicylate 50mg

    Menthol 20mg

    Analgesic in the treatment of gout pain. Helps relieve the condition of pain and stiffness.

    Drug facts

    Methyl salicylate 50mg

    Menthol 20mg

    Analgesic in the treatment of gout pain. Helps relieve the condition of pain and stiffness.

  • DOSAGE & ADMINISTRATION

    Dosage and Usage

    Adults 5ml maximum per day

    Apply on skin and gentle massage around painful area.

    Dosage and Usage

    Adults 5ml maximum per day

    Apply on skin and gentle massage around painful area.

  • INACTIVE INGREDIENT

    Other ingredients

    Arnica montana, peppermint, olive oil, grapefruit oil, eucalyptus oil, matricaria recutita, juniper berry oil, borage oil

  • KEEP OUT OF REACH OF CHILDREN

    Warnings

    For external use only. Stop use and ask doctor if rash occurs. Keep out reach of children. Protect this product from excessive heat and direct sun.

    Warnings

    For external use only. Stop use and ask doctor if rash occurs. Keep out reach of children. Protect this product from excessive heat and direct sun.

    Warnings

    For external use only. Stop use and ask doctor if rash occurs. Keep out reach of children. Protect this product from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    Gout reliever synergy

  • INGREDIENTS AND APPEARANCE
    GOUT RELIEVER SYNERGY 
    gout reliever synergy oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70470-1113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg  in 500 mg
    Inactive Ingredients
    Ingredient NameStrength
    JUNIPER BERRY OIL (UNII: SZH16H44UY)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    BORAGE OIL (UNII: F8XAG1755S)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Product Characteristics
    Colorbrown (Bottle Color) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70470-1113-5500 mg in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/01/2016
    Labeler - PHYTOPIA CO., LTD. (656940504)
    Registrant - PHYTOPIA CO., LTD. (656940504)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHYTOPIA CO., LTD.656940504manufacture(70470-1113)
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