Label: DERMATITICA SYNERGY FOR TREATMENT OF DERMATITIS- dermatitica oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 24, 2016

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  • ACTIVE INGREDIENT

    Drug Facts

    Cocoa butter (6%)

    As skin protectant.

  • PURPOSE

    Use

    Helps to reduce stretch marks.

  • DOSAGE & ADMINISTRATION

    Dosage Suggestion

    Pregnant 6ml Maximum Per Day

    Post-pragnant 6ml Maximum Per Day

  • INDICATIONS & USAGE

    Directions

    Apply on skin and gentlely massage around abdomen.

  • INACTIVE INGREDIENT

    Other Ingredients

    Rosa Canina Whole, Olive Oil, Citrus Aurantiifolia Leaf Oil, Citrus Aurantium Flower Oil, Evening Primrose Oil, Citrus Reticulata Fruit 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.

  • Stretch Marks Remover

    Stretch Marks Remover

    1818

  • INGREDIENTS AND APPEARANCE
    DERMATITICA SYNERGY  FOR TREATMENT OF DERMATITIS
    dermatitica oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70470-1008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER3.2 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    SANDALWOOD OIL (UNII: X7X01WMQ5F)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    ROSA CANINA WHOLE (UNII: P5R39F12N2)  
    TANSY OIL (UNII: 43J2812KE1)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Product Characteristics
    Colorbrown (50ml per bottle) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70470-1008-550 mL 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 finalpart34604/01/2016
    Labeler - PHYTOPIA CO., LTD. (656940504)
    Registrant - PHYTOPIA CO., LTD. (656940504)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHYTOPIA CO., LTD.656940504manufacture(70470-1008)
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