Label: ARNICA- 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 January 22, 2014

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  • Active ingredient:

    Arnica montana (Leopard's bane) 1X HPUS-7%

  • Purpose

    Arnica montana (Leopard's bane) 1X HPUS-7%...............trauma, muscle pain and stiffness, swelling from injuries, discoloration from bruising

  • REFERENCES

    The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

  • Uses

    For relief of muscle pain and stiffness due to minor injuries, overexertion and falls. Reduces pain and swelling, as well as discoloration from bruising.

  • Warnings

    For external use only.

    Do not use if tube seal is broken.

    When using this product avoid contact with eyes and open wounds.

    Stop use and ask a doctor if condition persists for more than 3 days or worsens.

    Keep out of reach of children.

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

  • Directions

    Apply a thin layer of Arnica Gel to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed.

  • Other information

    Store at 68-77°F (20-25°C)

  • Inactive ingredients

    Purified water, isopropyl alcohol, glycerin, sodium hydroxide, carbomer

  • CARTON

    image of cartonimage of tube

  • INGREDIENTS AND APPEARANCE
    ARNICA 
    arnica montana gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-711
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-711-011 in 1 CARTON
    173 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/22/2014
    Labeler - CVS PHARMACY (062312574)
    Registrant - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(59779-711)
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