Label: ARNICA 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 December 17, 2020

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  • INDICATIONS & USAGE

    Directions: FOR ORAL USE.

  • DOSAGE & ADMINISTRATION

    Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

  • ACTIVE INGREDIENT

    Active Ingredients: Arnica 4X, Echinacea (Purple coneflower) 4X, Mercurialis (Dog’s mercury) 4X, Solanum lycopersicum (Tomato) 4X, Apis (Honeybee) 5X, Baptisia (Wild indigo) 5X, Bryonia (White bryony) 5X, Colchicum (Meadow saffron) 5X, Eucalyptus 5X, Eupatorium (Hemp agrimony) 5X, Solanum dulcamara (Bittersweet nightshade) 5X, Acidum benzoicum (Benzoic acid) 6X, Rhus tox. (Sumac) 7X, Solanum nigrum (Black nightshade) 8X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Salt

  • 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.

  • QUESTIONS

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

    Lot:

  • PRINCIPAL DISPLAY PANEL

    Arnica comp.

  • INGREDIENTS AND APPEARANCE
    ARNICA COMP. 
    arnica comp. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-1339
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED4 [hp_X]  in 1 mL
    BAPTISIA AUSTRALIS ROOT (UNII: 7S944UTF9R) (BAPTISIA AUSTRALIS ROOT - UNII:7S944UTF9R) BAPTISIA AUSTRALIS ROOT5 [hp_X]  in 1 mL
    SOLANUM DULCAMARA FLOWER (UNII: W6J1279A6K) (SOLANUM DULCAMARA FLOWER - UNII:W6J1279A6K) SOLANUM DULCAMARA FLOWER5 [hp_X]  in 1 mL
    SOLANUM NIGRUM FRUIT (UNII: XA101YYV55) (SOLANUM NIGRUM FRUIT - UNII:XA101YYV55) SOLANUM NIGRUM FRUIT8 [hp_X]  in 1 mL
    MERCURIALIS PERENNIS (UNII: Q35465A1MA) (MERCURIALIS PERENNIS - UNII:Q35465A1MA) MERCURIALIS PERENNIS4 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA4 [hp_X]  in 1 mL
    SOLANUM LYCOPERSICUM FRUITING TOP (UNII: X636CG4BH0) (SOLANUM LYCOPERSICUM FRUITING TOP - UNII:X636CG4BH0) SOLANUM LYCOPERSICUM FRUITING TOP4 [hp_X]  in 1 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA5 [hp_X]  in 1 mL
    EUCALYPTUS GUM (UNII: 72T9EZC2VX) (EUCALYPTUS GUM - UNII:72T9EZC2VX) EUCALYPTUS GUM5 [hp_X]  in 1 mL
    COLCHICUM AUTUMNALE WHOLE (UNII: W79255C628) (COLCHICUM AUTUMNALE WHOLE - UNII:W79255C628) COLCHICUM AUTUMNALE WHOLE5 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT5 [hp_X]  in 1 mL
    EUPATORIUM CANNABINUM FLOWERING TOP (UNII: A5296YC7FS) (EUPATORIUM CANNABINUM FLOWERING TOP - UNII:A5296YC7FS) EUPATORIUM CANNABINUM FLOWERING TOP5 [hp_X]  in 1 mL
    BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID6 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF7 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-1339-110 in 1 BOX09/01/2009
    11 mL in 1 AMPULE; Type 1: Convenience Kit of Co-Package
    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(48951-1339)
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