Label: ARNICARE BRUISE- arnica montana cream

  • 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 May 23, 2023

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

View All Sections
  • 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

    Reduces pain, swelling, and discoloration from bruises*

  • INDICATIONS & USAGE

    Uses*

    reduces symptoms of bruising such as:

    • pain
    • swelling
    • discoloration
  • 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.
  • ASK DOCTOR

    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.
  • PREGNANCY OR BREAST FEEDING

  • 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

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

  • SPL UNCLASSIFIED SECTION

    Other information

    • 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)

    Net Wt. 1.4 oz (40g)

    Bruise Relief*

    Pain Swelling Discoloration*

    Moisturizing Formula

    Fade Bruises

    Fragrance-Free

    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.

  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or comments?

    Arnicare.com | BoironUSA.com

    Info@Boiron.com

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

  • PRINCIPAL DISPLAY PANEL

    LABELlabel

  • INGREDIENTS AND APPEARANCE
    ARNICARE BRUISE 
    arnica montana cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9085
    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
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYDROGENATED PALM/PALM KERNEL OIL PEG-6 ESTERS (UNII: 8EPU9MJ01K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    WATER (UNII: 059QF0KO0R)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9085-601 in 1 PACKAGE01/21/2021
    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 homeopathic01/21/2020
    Labeler - Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9085)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!