Label: ROSATRA SYNERGY FOR TREATMENT OF ACNE ROSACEA- rosatra 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 31, 2019

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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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