Label: MENSTRUAL PAIN SYNERGY FOR TREATMENT OF MENSTRUAL PAIN- menstrual pain 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 December 26, 2017

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  • ACTIVE INGREDIENT

    Drug Facts

    menthol 0.6mg

    Analgesic in the treatment of menstrual pain

  • PURPOSE

    Use:

    Menstrual Pain reliever

  • DOSAGE & ADMINISTRATION

    Dosage Suggestion

    Adults 4ml maximum per day

  • INDICATIONS & USAGE

    Directions

    Apply evenly to clean skin around lower abdomen. Simply apply 10~20 drops and rub into the skin. Apply twice a day. Can also use as a preventative by applying before menstrual.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Clary Sage Oil, Lavender Oil, Bergamot Oil, Olive Oil, Rose Hip Seed Oil, Evening Primrose 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.

  • MENSTRUAL PAIN Synergy

    MENSTRUAL PAIN

  • INGREDIENTS AND APPEARANCE
    MENSTRUAL PAIN SYNERGY  FOR TREATMENT OF MENSTRUAL PAIN
    menstrual pain oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70470-1805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    CLARY SAGE OIL (UNII: 87L0D4U3M0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    ROSA RUBIGINOSA SEED OIL (UNII: 8M1P49MWAP)  
    Product Characteristics
    Colorbrown (50ml per bottle) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70470-1805-550 mL in 1 BOTTLE, UNIT-DOSE; 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(70470-1805)
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