Label: IRIS GERMANICA COMP. 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 April 26, 2018

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  • INDICATIONS & USAGE

    Directions: FOR ORAL USE ONLY.

  • DOSAGE & ADMINISTRATION

    Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.

  • ACTIVE INGREDIENT

    Active Ingredients: Crataegus (Hawthorn) 3X, Carduus benedictus (Blessed thistle) 4X, Iris germanica (Iris) 4X, Paeonia (Peony) 4X, Kalium carb. (Potassium carbonate) 5X, Cor (Bovine heart) 6X, Aurum (Gold) 10X, Arnica 15X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Distilled water, Organic cane alcohol

  • PURPOSE

    Use: Temporary relief of headache.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

  • QUESTIONS

    Questions? Call 866.642.2858 Made with care by Uriel, East Troy, WI 53120 www.urielpharmacy.com

  • PRINCIPAL DISPLAY PANEL

    IrisGermanicaCompLiquid

  • INGREDIENTS AND APPEARANCE
    IRIS GERMANICA COMP. 
    iris germanica comp. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-5072
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36) (HAWTHORN LEAF WITH FLOWER - UNII:6OM09RPY36) HAWTHORN LEAF WITH FLOWER3 [hp_X]  in 1 mL
    CENTAUREA BENEDICTA (UNII: 6L5ZL09795) (CENTAUREA BENEDICTA - UNII:6L5ZL09795) CENTAUREA BENEDICTA4 [hp_X]  in 1 mL
    C12-17 ALKANE (UNII: FW7807707B) (C12-17 ALKANE - UNII:FW7807707B) C12-17 ALKANE4 [hp_X]  in 1 mL
    PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P) PAEONIA OFFICINALIS ROOT4 [hp_X]  in 1 mL
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE5 [hp_X]  in 1 mL
    BEEF HEART (UNII: P47W069U38) (BEEF HEART - UNII:P47W069U38) BEEF HEART6 [hp_X]  in 1 mL
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD10 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-5072-360 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Uriel Pharmacy Inc. (043471163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Uriel Pharmacy Inc.043471163manufacture(48951-5072)
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