Label: ARNICA GEL- arnica 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 July 15, 2021

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  • Drug facts

  • Active ingredient

    Arnica montana

    1X HPUS 7%

  • Inactive ingredients

    Alcohol, Carbomer, Purified water, Sodium Hydroxide

  • Dosage and administration

    Apply a thin layer of gel to affected area and massage gently as soon as possible after minor injury. Repeat 3 times a day or as needed.

  • Uses*

    • temporarily relieves muscel pain and stiffness due to minor injuries, over exertion and falls
    • reduces pain, swelling and discoloration from bruises
  • Warnings

    For external use only. Avoid contact with eyes, mucous membranes, damaged skin, or wounds.

    Do not use if you are allergic to Arnica montana or to any of thus product's inactive ingredients.

    When using this product

    • use only as directed
    • do not bandage tightly or use a heating pad.

    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 right away.

  • PURPOSE

    Trauma, muscle pain, and, stiffness, swelling from injuries, discoloration from bruising

  • Other information

    • Do not use if glued carton end flaps are open or if the tube seal is broken,
    • Store at 68-77 F (20-25 C)
  • Questions or comments?

    1-800-925-4733

  • PRINCIPAL DISPLAY PANEL

    carton

  • INGREDIENTS AND APPEARANCE
    ARNICA GEL 
    arnica gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0139
    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
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0139-2674 g in 1 PACKAGE; Type 0: Not a Combination Product07/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/15/2021
    Labeler - WALGREENS (008965063)
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