Label: ARNICARE BRUISE- 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 February 21, 2023

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  • Active Ingredients**

    Arnica montana 1X HPUS 7%

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

  • Purpose*

    Arnica montana 1X HPUS - Reduces pain, swelling and discoloration from bruises

  • Uses*

    reduces symptoms of bruising such as:

    • pain
    • swelling
    • discoloration

  • Warnings

    For external use only.

  • WHEN USING

    When using this product

    • avoid contact with eyes, mucus membranes, wounds, damage 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 the treated area immediately before or after use.
  • DO NOT USE

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

  • STOP USE

    Stop use and ask a doctor if

    • condition persists for more than 3 days or worsen
    • 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.

  • Directions

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

  • Other information

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

  • Inactive ingredients

    Alcohol, carbomer, purified water, sodium hydroxide

  • Questions, Comments?

    Arnicare.com

    BoironUSA.com

    info@boiron.com

    1-800-BOIRON-1

    (1-800-264-7661)

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

  • SPL UNCLASSIFIED SECTION

    1.5 oz (45g)

    Fragrance-Free

    Quickly Absorbs & Fades Bruises

    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.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ARNICARE BRUISE 
    arnica montana gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9084
    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 HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9084-541 in 1 PACKAGE02/01/2016
    145 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/01/2016
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9084)
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