PAINAWAY WITH NATURAL PEPPERMINT AND BALSAM PERU (PAINAWAY) OIL [PHYTOPIA CO., LTD.]

PAINAWAY WITH NATURAL PEPPERMINT AND BALSAM PERU (PAINAWAY) OIL [PHYTOPIA CO., LTD.]
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NDC 70470-1118-5
Set ID 2ff9542c-1e65-486a-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager PHYTOPIA CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART347
  • 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
    PAINAWAY  WITH NATURAL PEPPERMINT AND BALSAM PERU
    painaway oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70470-1118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.3 mg  in 50 mg
    BALSAM PERU OIL (UNII: DIK0395679) (BALSAM PERU OIL - UNII:DIK0395679) BALSAM PERU OIL1.2 mg  in 50 mg
    Inactive Ingredients
    Ingredient NameStrength
    LEMON OIL (UNII: I9GRO824LL)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    JAVA CITRONELLA OIL (UNII: DBD92X468R)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    EUCALYPTUS RADIATA LEAF OIL (UNII: SB9A7612BD)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    Product Characteristics
    Colorpurple (Violet Miron Bottle) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70470-1118-550 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 - BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO., LTD. (656368622)
    Establishment
    NameAddressID/FEIBusiness Operations
     BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO., LTD.656368622manufacture(70470-1118) , label(70470-1118) , pack(70470-1118)

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