Label: ROSA DAMASCENA- rosa x damascena flowering top pellet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 August 1, 2018

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  • ACTIVE INGREDIENTS

    ROSA DAM

  • USES

    To relieve the symptoms of bruised feeling.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines out of reach of children.

  • INDICATIONS

    Indications:

    ROSA DAM  Head congestion

  • 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

    The OTC potency range of ROSA DAM is 2x–30x, 1c–30c, 200c, 1m, 10m, 50m, and CM.

    Availability is subject to change.

    Label

    All WHP single remedies are made to order; thus, the labels are printed on the same label stock as the orders are filled.

    ‘Bottle Size’ and ‘Potency’ vary on the label depending on customer choice.

    Standard bottle sizes for pellet-form remedies are 2 dram, 4 dram, 1 ounce, 2 ounce, and 4 ounce.

  • INGREDIENTS AND APPEARANCE
    ROSA DAMASCENA 
    rosa x damascena flowering top pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68428-606
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROSA X DAMASCENA FLOWERING TOP (UNII: 21W82Q764G) (ROSA X DAMASCENA FLOWERING TOP - UNII:21W82Q764G) ROSA X DAMASCENA FLOWERING TOP30 [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:68428-606-0375 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/11/2011
    2NDC:68428-606-05150 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/11/2011
    3NDC:68428-606-11300 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/11/2011
    4NDC:68428-606-12600 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/11/2011
    5NDC:68428-606-061200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/11/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/11/2011
    Labeler - Washington Homeopathic Products (084929389)
    Establishment
    NameAddressID/FEIBusiness Operations
    Washington Homeopathic Products084929389manufacture(68428-606)
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