Label: 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 April 12, 2022

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  • ACTIVE INGREDIENT

    Arnica montana 1X HPUS 7%

  • INACTIVE INGREDIENT

    alcohol, carbomer, purified water, sodium hydroxide

  • DOSAGE & 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.

  • INDICATIONS & USAGE

    temporarily relieves muscle pain and stiffness due to minor injuries, overexertion and falls, reduces pain, swelling and discoloration from bruises

  • WARNINGS

    For external use only

    When using this product avoid contact with eyes, mucous membranes, damaged skin, or wounds.

    Do not use if you are allergic to Arnica montana or to any of this 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.

  • KEEP OUT OF REACH OF CHILDREN

    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 SAFETY 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).

  • PRINCIPAL DISPLAY PANEL

    CT515026LB515026

  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA 
    arnica montana gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5150
    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
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-5150-2674 g in 1 PACKAGE; Type 0: Not a Combination Product06/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/20/2019
    Labeler - WALGREENS CO. (008965063)
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