Label: CALENDULA OFFICINALIS KIT REFILL- calendula officinalis flowering top pellet

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 6, 2010

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  • ACTIVE INGREDIENTS

    CALENDULA OFFICINALIS    200C
  • USES

    To relieve the symptoms of wounds.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines out of reach of children.

  • INDICATIONS

    Indications:

    CALENDULA OFFICINALIS     Wounds
  • STOP USE AND ASK DOCTOR

    If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.

  • DIRECTIONS

    Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.

    Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.
  • INACTIVE INGREDIENTS

    Sucrose/Lactose

  • PRINCIPAL DISPLAY PANEL

    image of vial/cardEnter section text here

  • INGREDIENTS AND APPEARANCE
    CALENDULA OFFICINALIS KIT REFILL 
    calendula officinalis flowering top pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68428-037
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP200 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Colorwhite (white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68428-037-01750 in 1 VIAL, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/03/2010
    Labeler - Washington Homeopathic Products (084929389)
    Establishment
    NameAddressID/FEIBusiness Operations
    Washington Homeopathic Products084929389manufacture