Label: ARNICARE- arnica montana ointment

  • Category: HUMAN OTC DRUG LABEL

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 18, 2023

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  • ACTIVE INGREDIENT

    Arnica montana 1X HPUS 4%

  • INDICATIONS & USAGE

    Temporarily relives muscle pain and stiffness due to minor injuries, overexertion and falls. Reduces symptoms of bruising such as pain, swelling, discoloration

  • DO NOT USE

    Do not use if glued carton en flaps are open or if the tube seal is broken

    Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredient

  • DOSAGE & ADMINISTRATION

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

    Apply a thin layer of Arnicare Ointment to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying Arnicare Ointment.

  • INACTIVE INGREDIENT

    Alcohol, purified water, petrolatum USP

  • HOW SUPPLIED

    1 oz tube

  • PURPOSE

    Arnica montana 1X ...trauma, muscle pain and stiffness, swelling from injuries, discoloration from bruising.

  • STORAGE AND HANDLING

    Store at 68-77 O F (20-25 O C)

  • QUESTIONS

    Questions, Comments?

    arnicare.com
    boironusa.com

    info@boironusa.com

    1-800-BOIRON-1 (1-800-264-7661)



    Distributed by Boiron Inc.
    Newtown Square, PA 19073-3267


  • STOP USE

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

    Symptoms clear up and occur again within a few days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PREGNANCY OR BREAST FEEDING


  • WHEN USING

    avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin

    use only as directed

    do not tightly wrap or bandage treated area

    do not apply heat or ice to the treated area immediately before or after use

  • DRUG INTERACTIONS


  • WARNINGS

    For external use only
    Avoid contact with eyes and with open wounds.

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

  • SPL UNCLASSIFIED SECTION

    ɨ Homeopathic mother tincture made from Arnica montana fresh whole plant.

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
    *C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

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

  • PRINCIPAL DISPLAY PANEL

    LAbellabelboxArnicare Ointment Image

  • INGREDIENTS AND APPEARANCE
    ARNICARE 
    arnica montana ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9023
    Route of AdministrationCUTANEOUS
    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)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9023-5130 g in 1 BOX; Type 0: Not a Combination Product06/02/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/02/2007
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9023)
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