Label: ARNICARE VALUE PACK- arnica montana kit

  • 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 November 27, 2023

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

  • ACTIVE INGREDIENT

    Active ingredients**

    Arnicare Gel: Arnica Montana 1X HPUS 7%

    Arnica 30C pellets: (in each pellet) Arnica Montana 30C HPUS (0.443 mg)

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

  • INDICATIONS & USAGE

    Uses*
    temporarily relieves muscle pain and stiffness due to:

    • minor injuries
    • overexertion
    • falls

    reduces symptoms of bruising such as:

    • pain
    • swelling
    • discoloration
  • PURPOSE

    Purpose*

    Arnicare Gel: Arnica Montana 1X HPUS 7% ..... Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises
    Arnica 30C Pellets: Arnica montana 30C HPUS .......... Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises

  • WARNINGS

    Arnicare Gel: For external use only.

  • DO NOT USE

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

  • WHEN USING

    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 the 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.

    ARNICA 30C PELLETS:

    Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • 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

    ARNICARE GEL: Apply a thin layer of Arnicare Gel 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 Gel.

    ARNICA 30C PELLETS: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

  • INACTIVE INGREDIENT

    ARNICARE GEL: alcohol, carbomer, purified water, sodium hydroxide

    ARNICA 30C PELLETS: lactose, sucrose.

  • QUESTIONS

    Arnicare.com

    BoironUSA.com

    Info@Boiron.com

    1-800-BOIRON-1

    1-800-264-7661

  • SPL UNCLASSIFIED SECTION

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

    Quickly absorbed, non-greasy, fragrance-free, non-drowsy, no known drug interactions

    Pain Relief*

    Muscle Pain & Stiffness Swelling from Injuries Bruises*

    Local & General Pain

    Combine for Total Relief

    Gel: 1 tube 2.6 oz (75g)

    Pellets: + approx. 80 pellets

    How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.

    *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

    labelbox

  • INGREDIENTS AND APPEARANCE
    ARNICARE VALUE PACK 
    arnica montana kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9042
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9042-791 in 1 KIT11/01/2008
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 80 
    Part 21 TUBE 75 g
    Part 1 of 2
    ARNICA 
    arnica montana pellet
    Product Information
    Item Code (Source)NDC:0220-0508
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (Pellet) Size4mm
    FlavorImprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    180 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2008
    Part 2 of 2
    ARNICARE 
    arnica montana gel
    Product Information
    Item 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)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    175 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2008
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9042)