Label: ARNICA MONTANA NARTEX- arnica montana, hamamelis virginica ointment

  • NDC Code(s): 34666-007-16, 34666-007-28
  • 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 December 27, 2018

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  • ACTIVE INGREDIENT

    Arnica Montana TINC

    Hamamelis virginica TINC

  • PURPOSE

    Anti-inflammatory, pain reliever

  • INDICATIONS & USAGE

    for the temporary relief of

    • sore muscles
    • bruises
    • sprains

    as per homeopathic materia medica

  • WARNINGS

    Warnings:

    For external use only.

  • DO NOT USE

    Do not:

    • use if you have an allergy or hypersensitivity to components of the formula
    • apply to wounds or damaged skin
    • apply to children under 2 years of age

  • STOP USE

    Stop use and ask a doctor if:

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

    • adults and children over 2 years of age and older: apply generously rubbing into the affected area
    • reapply if needed
    • children under 2 years of age: consult a physician
  • INACTIVE INGREDIENT

    Glycerin, Lanolin wax, Sodium benzoate, Solid petrolatum, water

  • QUESTIONS

    Questions or comments?

    P.O. Box 1261, Downey CA 90240

    www.nartexlabs.com

  • PRINCIPAL DISPLAY PANEL

    Homeopathic relief for sore muscles, bruises and sprains.

    Arnica Montana Nartex Carton

  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA NARTEX 
    arnica montana, hamamelis virginica ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34666-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1.66 g  in 28 g
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) (HAMAMELIS VIRGINIANA LEAF - UNII:T07U1161SV) HAMAMELIS VIRGINIANA LEAF1.66 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34666-007-2828 g in 1 CONTAINER; Type 0: Not a Combination Product12/23/2010
    2NDC:34666-007-1616 g in 1 CONTAINER; Type 0: Not a Combination Product12/23/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/23/2010
    Labeler - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV (589914576)
    Registrant - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV (589914576)
    Establishment
    NameAddressID/FEIBusiness Operations
    NARTEX LABORATORIOS HOMEOPATICOS SA DE CV589914576manufacture(34666-007)
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