ROSATRA SYNERGY FOR TREATMENT OF ACNE ROSACEA (ROSATRA) OIL [PHYTOPIA CO., LTD.]

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ROSATRA SYNERGY FOR TREATMENT OF ACNE ROSACEA (ROSATRA) OIL [PHYTOPIA CO., LTD.]
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NDC 70470-1001-5
Set ID 3f9f6bd4-58bf-4b49-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager PHYTOPIA CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART356
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  • Warning

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

    Warning

    Keep out reach of children.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • ACTIVE INGREDIENT

    Drug Facts

    Eucalyptol 0.7g

    For the treatment of Acne Rosacea, helps to relieve the symptoms of facial redness, dilated blood vessels.

  • DOSAGE & ADMINISTRATION

    Dosage and Usage

    Adults 5ml maximum per day

    Children 1ml maximum per day

    Apply on skin and gentle massage around affected areas.

  • INACTIVE INGREDIENT

    Other Ingredients

    Calendula Officinalis Seed Oil, Almond Oil, Evening Primrose Oil, Olive Oil, Carrot Seed Oil, Chamomile Flower Oil, Helichrysum Italicum Flower Oil.

  • PRINCIPAL DISPLAY PANEL

    1001

  • INGREDIENTS AND APPEARANCE
    ROSATRA SYNERGY  FOR TREATMENT OF ACNE ROSACEA
    rosatra oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70470-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.7 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    Product Characteristics
    Colorbrown (50ml per bottle) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70470-1001-550 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/29/2016
    Labeler - PHYTOPIA CO., LTD. (656940504)
    Registrant - BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO., LTD. (656368622)
    Establishment
    NameAddressID/FEIBusiness Operations
     BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO., LTD.656368622manufacture(70470-1001)
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