Label: ARNICARE ARTHRITIS- arnica montana, harpagophytum procumbens root, harpagophytum zeyheri root cream

  • NDC Code(s): 0220-9077-63, 0220-9077-69, 0220-9077-82, 0220-9077-83, view more
    0220-9077-93
  • Packager: 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 March 5, 2024

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

  • ACTIVE INGREDIENT

    Active ingredients**

    Arnica montana 1X HPUS 7%

    Harpagophytum 1X HPUS 3%

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

  • PURPOSE

    Purpose*

    Arnica montana 1X HPUS 7% ... Relieves muscle pain and stiffness, discoloration from bruises

    Harpagophytum 1X HPUS 3% ... Relieves joint discomfort and stiffness associated with arthritis pain

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves minor joint and muscle pain and stiffness due to:

    arthritis
    minor injuries
    overexertion
    falls
    repetitive motions

  • WARNINGS

    For external use only.

  • DO NOT USE

    • if you are allergic to Arnica montana, Harpagophytum or to any of this product's inactive ingredients
    • with other topical products for pain
  • WHEN USING

    • 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

    • conditions persists for more than 7 days or worsens
    • symptoms clear up and occur again within a few days.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, 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

    • Adults and children 12 years of age and older: Apply a thin layer of Arnicare Arthritis to affected area as soon as possible at the onset of symptoms up to 4 times a day. If heat or ice is applied, wait 5 minutes before applying Arnicare Arthritis.
    • Children under 12 years of age: Ask a doctor.
  • SPL UNCLASSIFIED SECTION

    • do not use if glued carton end flaps are open or if the tube seal is broken
    • store below 77° F (25° C)
    • do not use if pouch is torn or open
    • dispose of 1 day after opening
  • INACTIVE INGREDIENT

    acrylamide/sodium acryloyldimethyltaurate copolymer , alcohol, chlorhexidine digluconate, glycerin, isohexadecane, polysorbate 80, purified water, sorbitan oleate, sweet almond oil

  • QUESTIONS

    Questions or comments?

    Arnicare.com

    BoironUSA.com

    Info@Boiron.com

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

    Made in France

    Distributed by Boiron, Inc.

    Newtown Square, PA 19073

  • SPL UNCLASSIFIED SECTION

    0.18 oz (5 g)

    0.5 oz (14 g)

    2.5 oz (70 g)

    4.2 oz (120 g)

    Arthritis Pain Relief*

    Quickly-Absorbing Cream

    Fragrance-Free

    Powered by Plants

    No Known Drug Interactions

    Dual Action Pain Relief*

    4.2 oz (120g) Pump:

    HOW TO OPEN

    1 Pull to remove safety clip from pump.

    2 Twist top clockwise to open.

    3 Pump until cream dispense.

    *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

    labellabellabellabellabellabellabellabellabellabellabellabellabellabellabel

  • INGREDIENTS AND APPEARANCE
    ARNICARE ARTHRITIS 
    arnica montana, harpagophytum procumbens root, harpagophytum zeyheri root cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89) (HARPAGOPHYTUM PROCUMBENS ROOT - UNII:1OYM338E89) HARPAGOPHYTUM PROCUMBENS ROOT1 [hp_X]  in 1 g
    HARPAGOPHYTUM ZEYHERI ROOT (UNII: 1CTB7R80VI) (HARPAGOPHYTUM ZEYHERI ROOT - UNII:1CTB7R80VI) HARPAGOPHYTUM ZEYHERI ROOT1 [hp_X]  in 1 g
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ACRYLAMIDE (UNII: 20R035KLCI)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9077-631 in 1 BOX03/17/2022
    170 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0220-9077-691 in 1 BOX03/17/2022
    214 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0220-9077-831 in 1 BOX03/28/2023
    3120 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0220-9077-935 g in 1 POUCH; Type 0: Not a Combination Product06/09/2023
    5NDC:0220-9077-821 in 1 BOX07/17/2023
    5120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/17/2022
    Labeler - Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9077)