Label: ARNICARE- arnica montana gel

  • NDC Code(s): 0220-9000-54, 0220-9000-59, 0220-9000-65, 0220-9000-66, view more
    0220-9000-84, 0220-9000-86
  • Packager: Laboratoires Boiron
  • 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 October 21, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient**

    Arnica montana 1X HPUS 7%

    The letters HPUS indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    Purpose*

    Arnica montana 1X HPUS Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves muscle pain and stiffness due to:

    • minor injuries
    • overexertion
    • falls
    • reduces symptoms of bruising such as:
    • pain
    • swelling
    • discoloration

  • WARNINGS

    Warnings

    For external use only.

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

    When using this product

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

    use only as directed

    dryness or irritation may occur

    do not tightly wrap or bandage the treated area

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

  • STOP USE

    Stop use and ask a doctor 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply a thin layer of Arnicare Gel to the 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 Gel

    Arnicare Gel Roll-On - Shake well before each use. With the applicator facing down, lightly squeeze the tube then roll ball against skin to apply a thin layer of the product to affected area. Massage gently into skin 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying Arnicare Roll-on.

  • INACTIVE INGREDIENT

    Alcohol, carbomer, sodium hydroxide. purified water

  • SPL UNCLASSIFIED SECTION

    Other information

    do not use if glued carton end flaps are open or if the tube seal is broken

    0.5 oz (14g)

    1.5 oz (45g)

    2.6 oz (75g)

    4.2 oz (120g)

    Pain Relief*

    Muscle Pain & Stiffness Swelling from Injuries Bruises*

    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.

  • QUESTIONS

    Questions, Comments?

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

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

    Arnicare.com

    Made in France

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ARNICARE 
    arnica montana gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9000
    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 HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9000-661 in 1 PACKAGE01/09/2007
    1120 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0220-9000-591 in 1 PACKAGE01/09/2007
    275 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0220-9000-541 in 1 PACKAGE01/09/2007
    345 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0220-9000-651 in 1 PACKAGE01/09/2007
    414 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:0220-9000-841 in 1 PACKAGE06/01/2018
    545 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:0220-9000-862 in 1 PACKAGE06/01/2018
    645 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/09/2007
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9000)