Label: ARNICA CALENDULA SPECIAL ORDER powder

  • 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 29, 2014

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  • INDICATIONS & USAGE

    Directions: FOR ORAL USE ONLY.

  • DOSAGE & ADMINISTRATION

    Take 3-4 times daily. Ages 12 and older: 1/8 teaspoon. Ages 2-11: 1/16 teaspoon. Under age 2: Consult a doctor.

  • ACTIVE INGREDIENT

    Active Ingredient: 100gm contains: 2.5gm Arnica e flor. 1X, 1.65gm Calendula ex herba 1X, 1.65 Echinacea ex herba 1X, 0.1gm Quartz 1X, 0.1gm Stibium 1X

  • INACTIVE INGREDIENT

    Inactive Ingredient: Diatomaceous earth

  • PURPOSE

    Use: Temporary relief of minor bruises, cuts and scrapes.

  • 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.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    PRODUCT LABEL

  • INGREDIENTS AND APPEARANCE
    ARNICA CALENDULA SPECIAL ORDER 
    arnica calendula special order powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-1248
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER1 [hp_X]  in 1 g
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 1 g
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA1 [hp_X]  in 1 g
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) COLLOIDAL SILICON DIOXIDE1 [hp_X]  in 1 g
    ANTIMONY (UNII: 9IT35J3UV3) (ANTIMONY - UNII:9IT35J3UV3) ANTIMONY1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-1248-420 g in 1 BOTTLE, GLASS
    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(48951-1248)
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