KELOID HEALER SYNERGY FOR TREATMENT OF KELOIDS (KELOID HEALER) OIL [PHYTOPIA CO., LTD.]

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KELOID HEALER SYNERGY FOR TREATMENT OF KELOIDS (KELOID HEALER) OIL [PHYTOPIA CO., LTD.]
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NDC 70470-1020-5
Set ID 3fa1a19a-4a82-1fad-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager PHYTOPIA CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART347
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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
    KELOID HEALER SYNERGY  FOR TREATMENT OF KELOIDS
    keloid healer oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70470-1020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL1.3 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
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    ST. JOHN'S WORT (UNII: UFH8805FKA)  
    NIAOULI OIL (UNII: D50IC2T8FU)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    EUCALYPTUS RADIATA LEAF OIL (UNII: SB9A7612BD)  
    Product Characteristics
    Colorbrown (50ml per bottle) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70470-1020-5500 mg in 1 BOTTLE, GLASS; 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(70470-1020)
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