Label: ARNICA GEL 90- arnica montana flower water gel

  • NDC Code(s): 86049-001-01, 86049-001-02
  • Packager: OFFICINALIS SRL SOCIETA' AGRICOLA
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 19, 2023

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  • Active Ingredient


    Arnica Montana Flower Water

  • Ingredients

    Arnica Montana Flower Extract, Sodium Hydroxide, Glycerin, Propylene Glycol, Carbomer, Hydogenated Castor Oil, Mentha Piperita Oil, Salvia Officinalis Extract, Thymus Vulgaris Extract, Phenoxyethanol, Benzyl Alcohol, Potassium Sorbate, Tocopherol, EDTA.

  • Directions:

    clean the area thoroughly, massage the product where needed until it is completely absorbed. Do not apply product on open wounds.

    External Use Only

  • PRINCIPAL DISPLAY PANEL

    The nature of Horses
    OFFICINALIS®

    with Arnica Montana and Thyme Oil

    www.officinalis.net

    500ml e 17fl.oz.

    Produced by /

    Azienda Agricola OFFICINALIS
    Via Pedervia, 1
    36040 Grancona (VI) ITALIA

    www.officinalis.net

    Distributed by /

    BRUNO DALLA GRANA MANGIMI srl
    Via Zara, 74
    36045 Lonigo (VI) - ITALIA
    Tel. (0039) 0444 830501
    dallagranamangimi@libero.it

  • PRINCIPAL DISPLAY PANEL

    LABEL1

  • INGREDIENTS AND APPEARANCE
    ARNICA GEL 90 
    arnica montana flower water gel
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86049-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER820 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    THYME (UNII: CW657OBU4N)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86049-001-01500 mL in 1 BOTTLE
    2NDC:86049-001-021000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/18/2015
    Labeler - OFFICINALIS SRL SOCIETA' AGRICOLA (441513267)
    Establishment
    NameAddressID/FEIBusiness Operations
    OFFICINALIS SRL SOCIETA' AGRICOLA441513267manufacture, api manufacture
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