Label: ROSA DAMASCENA- rosa x damascena flowering top liquid

  • 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 February 11, 2011

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    ROSA DAM

  • USES

    To relieve the symptoms of head congestion.

  • 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, consult your practitioner.

  • DIRECTIONS

    Adults: 4 drops into a tsp. of water 3 times a day. Children: 1/2 dose. Repeat at greater intervals as condition subsides. Or as directed bya lic. practitioner.

  • 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.

    Rosa dam label example

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

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

    Standard bottle sizes for dilution-form remedies are 15ml, 30ml, 50ml, and 100ml.

  • INGREDIENTS AND APPEARANCE
    ROSA DAMASCENA 
    rosa x damascena flowering top liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71919-589
    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]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71919-589-0715 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product02/11/2011
    2NDC:71919-589-0830 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product02/11/2011
    3NDC:71919-589-0950 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/11/2011
    4NDC:71919-589-10100 mL 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(71919-589)