Label: ARNICA PAIN RELIEF- arnica montana gel

  • 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 November 15, 2022

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  • Drug Facts

  • Active ingredient

    Mountain arnica (Arnica montana) 3X HPUS

    The letters 'HPUS' indicate thant the component in this product is officially monographed in the Homoeopathic Pharmacopoeia of the United States.

    Purpose

    Pain reliever

  • Use

    temporarily relieves minor aches and pains associated with sore muscles, joint discomfort, strains, sprains, arthritis, and bruises.

  • Warnings

    For external use only.

    Avoid contact with eyes.

    Do not use

    • on open wounds 
    • cuts 
    • damaged skin
    • infected skin.

    Stop use and ask a doctor if

    symptoms persist for more than 7 days or worsens.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 2 years and above:
    • Apply a thin layer to affected area and surrounding areas as soon as possible after injury.
    • Lightly rub in and reapply after 30 seconds.
    • Repeat 4 times a day for 3 to 5 days.
    • When pain has subsided, apply once each morning and evening for continued temporary relief.
  • Other information:

    Store tightly closed in a cool, dry place.

  • Inactive ingredients

    Aloe vera leaf juice, benzoic acid, carbomer 940, emu oil, eucalyptus oil, glycerin, PEG-40 hydrogenated castor oil, phenoxyethanol, sodium hydroxide, sorbic acid

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ARNICA PAIN RELIEF 
    arnica montana gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43689-0034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    EMU OIL (UNII: 344821WD61)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43689-0034-1113 g in 1 JAR; Type 0: Not a Combination Product06/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/20/2017
    Labeler - Magni Group (113501902)
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