Label: SWELLING SOLUTION - IMPROVING LYMPHATIC DRAINAGE- peppermint 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 May 1, 2016

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  • ACTIVE INGREDIENT

    Drug Facts

    Peppermint Oil 13mg

    Sage Oil 5.3mg

    As.edema prevention and swelling relieving.

  • PURPOSE

    Use

    Helps to reduce water retention. Specially designed for improving lymphatic drainage.

  • DOSAGE & ADMINISTRATION

    Dosage Suggestion

    Adults 5ml Maximum Per Day

  • INDICATIONS & USAGE

    Directions

    Apply on skin and massage around the whole body.

  • INACTIVE INGREDIENT

    Other Ingredients

    Citrus Limon Fruit Oil, Grape Seed Oil, Jojoba Oil, Sunflower Oil, Sweet Marjoram Oil, Olive Oil,

    Pine Needle Oil (Pinus Sylvestris).

  • PREGNANCY OR BREAST FEEDING

    Warnings

    For external use only. Stop use and ask doctor if rash occurs. Keep out of reach of children. Do not use during pregnancy.

  • KEEP OUT OF REACH OF CHILDREN

    Warnings

    For external use only. Stop use and ask doctor if rash occurs. Keep out of reach of children. Do not use during pregnancy.

  • WARNINGS

    Warnings

    For external use only. Stop use and ask doctor if rash occurs. Keep out of reach of children. Do not use during pregnancy.

  • STORAGE AND HANDLING

    Other Information

    Protect this product from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    Swelling Solution- improving lymphatic drainage.

    8003

  • INGREDIENTS AND APPEARANCE
    SWELLING SOLUTION  - IMPROVING LYMPHATIC DRAINAGE
    peppermint oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70470-8003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PEPPERMINT (UNII: V95R5KMY2B) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT13 mg  in 50 mL
    SAGE OIL (UNII: U27K0H1H2O) (SAGE OIL - UNII:U27K0H1H2O) SAGE OIL5.3 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SWEET MARJORAM OIL (UNII: ICH7BE016E)  
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    Product Characteristics
    Colorpurple (in 50ml miron glass) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70470-8003-550 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/01/2016
    Labeler - PHYTOPIA CO., LTD. (656940504)
    Registrant - PHYTOPIA CO., LTD. (656940504)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHYTOPIA CO., LTD.656940504manufacture(70470-8003)
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