Label: SHAPING WITHOUT WORKOUT- menthol 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 5, 2016

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  • ACTIVE INGREDIENT

    Drug Facts

    Sage Oil 3mg

    Eucalyptol 4.3mg

    As Weight Control And Skin Astringent.

  • PURPOSE

    Use

    Helps to reduce weight, relief the symptom of oedema, and increase the metabolism of fat tissue. Especially designed for people on diet.

  • DOSAGE & ADMINISTRATION

    Dosage Suggestion

    Adults 7ml Maximum Per Day

  • INDICATIONS & USAGE

    Directions

    Apply on skin and massage around the whole body.

  • INACTIVE INGREDIENT

    Other Ingredients

    Grapefruit Oil, Jojoba Oil, Anise Oil, Eucalyptus Dives Leafy Twig Oil, Juniper Berry Oil, Olive Oil, Sunflower Oil, Argan Oil

  • 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.

  • WARNINGS

    Warnings

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

  • STORAGE AND HANDLING

    Other Information

    Protect this product from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    Shaping w/o Workout

    8001

  • INGREDIENTS AND APPEARANCE
    SHAPING WITHOUT WORKOUT 
    menthol oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70470-8001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL4.3 mg  in 50 mL
    SAGE OIL (UNII: U27K0H1H2O) (SAGE OIL - UNII:U27K0H1H2O) SAGE OIL3 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS DIVES LEAFY TWIG OIL (UNII: 329E5SO80L)  
    ANISE OIL (UNII: 6Y89129C8H)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    JUNIPER BERRY OIL (UNII: SZH16H44UY)  
    JOJOBA OIL (UNII: 724GKU717M)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    Product Characteristics
    Colorpurple (in 50ml miron glass) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70470-8001-550 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(70470-8001)
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