Label: 365 EVERYDAY VALUE ARNICA- arnica montana gel

  • NDC Code(s): 42681-0512-5, 42681-0512-6
  • Packager: WFM Private Label, LP
  • 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 July 18, 2023

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Arnica montana 1X HPUS - 7%

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

  • PURPOSE

    Purpose*

    Arnica montana 1X HPUS - 7% ... Trauma, bruises, stiffness, muscle soreness

  • INDICATIONS & USAGE

    Uses*

    For relief of muscle aches and stiffness due to:

    • minor injuries
    • strains
    • falls and blows
    • Reduces pain, swelling and discoloration from bruises
  • 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
    • 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
  • ASK DOCTOR

    Stop use and ask a doctor if

    • condition persists for more than 3 days or worsens
    • symptoms clear up and reoccur within a few days
  • 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 Arnica 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 Arnica Gel.

  • SPL UNCLASSIFIED SECTION

    Other information

    • do not store above 86° F (30° C)
    • do not use if glue carton end flaps are open or if tube seal is broken

  • INACTIVE INGREDIENT

    Inactive ingredients alcohol, carbomer, purified water, sodium hydroxide

  • SPL UNCLASSIFIED SECTION

    Pain relief of sore muscles, swelling, stiffness & bruising*

    Homeopathic Medicine

    NET WT 2.6 OZ (75g)

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

    †C,K,CK, and X are homeopathic dilutions: see www.theAAHP.org for details

  • QUESTIONS

    Questions or comments?

    1-844-WFM-TALK (1-844-936-8255)

    Distributed by:

    Whole Foods Market

    Austin, TX 78703

    © 2020 WHOLE FOODS MARKET IP, LP

    www.wholefoodsmarket.com

    MADE IN FRANCE

  • PREGNANCY OR BREAST FEEDING


  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    365 EVERYDAY VALUE ARNICA 
    arnica montana gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42681-0512
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42681-0512-51 in 1 BOX; Type 0: Not a Combination Product09/01/2008
    2NDC:42681-0512-61 in 1 BOX; Type 0: Not a Combination Product01/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2008
    Labeler - WFM Private Label, LP (196175616)