Label: HAMAMELIS E CORTEX 3 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 September 8, 2014

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  • INDICATIONS & USAGE

    Directions: FOR ORAL USE.

  • 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 Ingredient: Hamamelis e cortex 3X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Salt, Sodium bicarbonate, Rose oil

  • PURPOSE

    Use: Temporary relief of burns.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    Warnings: 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.

    REFRIGERATE AFTER OPENING. USE WITHIN 30 DAYS OF OPENING.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    PRODUCT BOTTLE LABEL

    PRODUCT BAG LABEL

  • INGREDIENTS AND APPEARANCE
    HAMAMELIS E CORTEX 3 
    hamamelis e cortex 3 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-5030
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) (HAMAMELIS VIRGINIANA TOP - UNII:UDA30A2JJY) HAMAMELIS VIRGINIANA TOP3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ROSE OIL (UNII: WUB68Y35M7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-5030-11 in 1 BAG
    17 mL in 1 BOTTLE, DROPPER
    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(48951-5030)
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