Label: ARNICA 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 January 18, 2023

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

  • ACTIVE INGREDIENT

    Arnicare Cream:

    Arnica Montana 1X HPUS 7%*



    Arnica 30 C pellets:

    Arnica Montana 30C HPUS (0.443 mg)*

  • INDICATIONS & USAGE

    Arnicare cream and Arnica 30 C pellets
    Temporary relieves muscle pain and stiffness due to minor injuries, overexertion and falls. Reduces pain, swelling and discoloration from bruises.

  • INACTIVE INGREDIENT

    Arnicare Cream Value Pack:

    Cream: alcohol, caprylyl, glycol, carbomer, cetyl palmitate, EDTA disodium, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol.

    Pellets: Lactose, Sucrose.

    Arnicare Cream Value Pack (without disodium EDTA):

    Cream: alcohol, caprylyl, glycol, carbomer, cetyl palmitate, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol.

    Pellets: Lactose, Sucrose.

  • HOW SUPPLIED

    Cream:
    1 tube 2.5 OZ (70g)

    Pellets:
    1 tube approx. 80 pellets each, 3.8g (0.133 oz.)


  • PURPOSE

    Cream:
    Arnica Montana 1X HPUS-7% ..... Trauma, muscle, pain and stiffness, swelling from injuries, discoloration from bruising.

    Pellets:
    Arnica montana 30C HPUS .......... Trauma, bruises and muscle soreness.


  • STORAGE AND HANDLING

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

  • QUESTIONS

    Questions, Comments

    www.arnicare.com

    info@boironusa.com

    1-800-BOIRON-1

    (1-800-264-7661)

  • ASK DOCTOR


  • STOP USE

    Cream:
    Stop use and ask a doctor if condition persists for more than 3 days or worsens.

    Pellets:
    Stop use and ask a doctor if condition persists for more than 3 days or worsens.

  • KEEP OUT OF REACH OF CHILDREN

    Cream:
    Keep out of reach of children
    If swallowed get medical help or contact a Poison Control Center right away.

    Pellets:
    Keep out of reach of children

  • WHEN USING

    avoid contact with eyes, mucus membranes, wounds, damaged or irrated skin

    use only as directed

    do not tightly wrap or bandage the treated area

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

  • DRUG INTERACTIONS

    Unscented -Paraben free -Great for massage - Works naturally with your body.

  • WARNINGS

    Arnicare Cream:

    For external use only.

    Avoid contact with eyes and with open wounds.


  • DOSAGE & ADMINISTRATION

    Cream:

    Apply a thin layer of Arnicare Cream of affected area and massage gently 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 Cream.


    Pellets:

    Adults and children 2 years of age and older: Dissolve 5 pellets in the mouth 3 times a day until relieved or as directed by a doctor.

    How to use Arnica 30C Pellets: Turn tube upside down. Twist until 5 pellets are dispensed

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • 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.

    For general pain relief, Arnica 30C pellets can be take alone or as a complement to Arnicare Cream.

    Non-drowsy

    No known drug interactions

    Local & General Pain

    Combine for total relief

  • PRINCIPAL DISPLAY PANEL

    labelvalue pack boxnon EDTA boxtube

  • INGREDIENTS AND APPEARANCE
    ARNICA VALUE PACK 
    arnica montana kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9047
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9047-781 in 1 BOX11/01/2008
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 80 
    Part 21 TUBE 70 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 cream
    Product Information
    Item Code (Source)NDC:0220-9021
    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
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER 934 (UNII: Z135WT9208)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYDROGENATED PALM/PALM KERNEL OIL PEG-6 ESTERS (UNII: 8EPU9MJ01K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    170 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(0220-9047)