Label: ARNICARE FOOT CARE- arnica montana cream

  • Category: HUMAN OTC DRUG LABEL

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 May 23, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient **

    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

    Purpose*

    Relieves pain & soreness, swelling from injuries, discoloration from bruises

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves symptoms of overexertion and minor injuries such as:

    • sore feet
    • aches
    • pains
    • reduces symptoms of sprains and strains such as:
    • pain
    • swelling
    • discoloration from bruises
  • WARNINGS

    Warnings

    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
    • 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 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 Poions Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply a thin layer of Arnicare FootCare to affected area and massage gently 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying Arnicare FootCare.

  • SPL UNCLASSIFIED SECTION

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

    store at 68-77° F (20-25° C)

    4.2 oz (120g)

    Moisturizing

    Fragrance-Free

    Plant-Based Relief

    Sore & Aching Feet Swelling from Sprains Joint Pain*

    Foot Pain Relief*

    *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.

  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Arnicare.com

    BoironUSA.com

    Info@Boiron.com

    1-800-BOIRON-1

    (1-800-264-7661)

    Distributed by Boiron Inc.

    Newtown Square, PA 19073-3267

  • PRINCIPAL DISPLAY PANEL

    labelLabeltubebox

  • INGREDIENTS AND APPEARANCE
    ARNICARE FOOT CARE 
    arnica montana cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9055
    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 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED PALM/PALM KERNEL OIL PEG-6 ESTERS (UNII: 8EPU9MJ01K)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBIC ACID (UNII: X045WJ989B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9055-821 in 1 PACKAGE06/01/2018
    11 [hp_X] in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2018
    Labeler - Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9055)
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