Label: STROKE II SYNERGY oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 5, 2018

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  • ACTIVE INGREDIENT

    Drug Facts

    menthol(2.6%)

    Balsam Peru Oil (2.4%)

    Analgesic in the treatment of muscle pain

  • PURPOSE

    Use

    Helps relieve the condition of pain and stiffness.

  • DOSAGE & ADMINISTRATION

    Dosage Suggestion

    Adults 5ml maximum per day

    Children 1ml maximum per day

  • INDICATIONS & USAGE

    Directions

    Apply on skin and gentle massage around painful area.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    EUCALYPTUS RADIATA LEAF OIL, JAVA CITRONELLA OIL, SUNFLOWER OIL, JOJOBA OIL, ROSEMARY OIL, EVENING PRIMROSE OIL, LEMON OIL, LAVENDER 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.

  • STORAGE AND HANDLING

    Other Information

    Protect this product from excessive heat

    and direct sun.

  • WARNINGS

    Warnings

    For external use only. Stop use and ask doctor if rash occurs. Keep out reach of children.

  • PainAway-With natural Peppermint and Balsam Peru Oil

    PainAway

  • INGREDIENTS AND APPEARANCE
    STROKE II SYNERGY 
    stroke ii synergy oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70470-1225
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.4 mg  in 50 mg
    BALSAM PERU OIL (UNII: DIK0395679) (BALSAM PERU OIL - UNII:DIK0395679) BALSAM PERU OIL1.6 mg  in 50 mg
    Inactive Ingredients
    Ingredient NameStrength
    LEMON OIL (UNII: I9GRO824LL)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
    Product Characteristics
    Colorpurple (Violet Miron Bottle) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70470-1225-550 mg in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34704/01/2016
    Labeler - PHYTOPIA CO., LTD. (656940504)
    Registrant - PHYTOPIA CO., LTD. (656940504)
    Establishment
    NameAddressID/FEIBusiness Operations
    Phytopia Co., Ltd.656940504manufacture(70470-1225)
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