Label: ARNICA MONTANA NARTEX- arnica montana, hamamelis virginiana gel

  • NDC Code(s): 34666-400-01
  • Packager: Nartex Laboratorios Homeopaticos, S.A. de C.V.
  • 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 3, 2021

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  • Active Ingredients

    Each dose contains equal parts of:

    Arnica montana TINC HPUS*

    Hamamelis virginiana TINC HPUS*

    *The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. TINC is an homeopathic dilution. See www.nartexlabsusa.com for more information.

  • Purpose

    Arnica montana TINC HPUS*................Anti-inflammatory/Pain relief

    Hamamelis virginiana TINC HPUS*.....................Anti-inflammatory/Pain relief

  • Uses

    Temporary relief for the symptoms of sore muscles, bruises and sprains.

    Claims based on traditional homeopathic practice, not accepted medical evidence. The uses have not been evaluated by FDA, and product has not been clinically tested.

  • Warnings

    For external use only.

    Do not

    • apply to wounds or damaged skin.
    • apply over large areas of the body.

    When using this product

    • avoid contact with eyes or mucous membranes.
    • do not bandage tightly.

    Stop use and ask doctor if

    • symptoms persist for more than 7 days or clear up and occur again within a few days.
    • rash develops.

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

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

  • Directions

    • adults and children over 2 years of age: apply generously rubbing into affected area as needed.
    • children 2 years of age: consult a physician.
  • Other information

    • do not use if the tube seal is broken or missing.
    • store at room temperature.
  • Inactive ingredients

    Alcohol, Carbomer, Purified water, Sodium hydroxide

  • Questions or comments?

    informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm CST

  • PRINCIPAL DISPLAY PANEL

    Arnica Montana Nartex

    Gel

    New Formula

    Homeopathic

    temporary

    relief for the

    symptoms of

    Sore Muscles,

    Bruises and Sprains.

    Arnica & Hamamelis

    Claims based on traditional homeopathic practice, not accepted medical evidence.

    Not FDA evaluated.

    Unscented

    Non-Greasy

    Paraben Free

    cGMP Quality

    Nartex US

    Homeopathic

    Absorbs quickly

    For external use only

    Net Wt. 2.6 oz (74 g)

    1

    2

  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA NARTEX 
    arnica montana, hamamelis virginiana gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34666-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU) (HAMAMELIS VIRGINIANA WHOLE - UNII:V663Q8TEFU) HAMAMELIS VIRGINIANA WHOLE1 [hp_X]  in 1 g
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34666-400-011 in 1 CARTON04/30/2021
    174 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/30/2021
    Labeler - Nartex Laboratorios Homeopaticos, S.A. de C.V. (589914576)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nartex Laboratorios Homeopaticos, S.A. de C.V.589914576manufacture(34666-400)
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