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

  • NDC Code(s): 34666-001-30
  • Packager: NARTEX LABORATORIOS HOMEOPATICOS SA DE CV
  • 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 January 23, 2022

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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

    Each dose contains equal parts of:

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

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

    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.

  • Uses

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

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

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

    Glycerin, Lanolin, Paraffin, Sodium benzoate, Water, White petrolatum

  • Questions or comments?

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

  • Principal Display Panel

    NDC 34666-001-30

    Arnica Montana Nartex Cream

    Homeopathic temporary relief for the symptoms of Sore Muscles, Bruises and Sprains.

    Arnica & Hamamelis

    For external use only

    Paraben free

    Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated and not clinically tested.

    Homeopathic

    Net Wt. 2.6oz (74 g)

    1

    2

  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA NARTEX 
    arnica montana, hamamelis virginiana cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34666-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1.73 g  in 29.7 g
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) (HAMAMELIS VIRGINIANA LEAF - UNII:T07U1161SV) HAMAMELIS VIRGINIANA LEAF0.0178 g  in 29.7 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34666-001-301 in 1 CARTON01/21/2022
    174 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/21/2022
    Labeler - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV (589914576)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS HOMEOPATICOS SA DE CV589914576manufacture(34666-001)
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