Label: ARNICA TREATMENT PACK kit

  • NDC Code(s): 34666-020-01
  • 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 April 11, 2019

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

  • Arnica Treatment Pack - Arnica Recovery Tablets

  • Drug Facts

  • Active Ingredient (in each tablet)

    Arnica Montana 6C HPUS*

    *The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "C" is an homeopathic dilution. See www.nartexlabsusa.com formore information. Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

  • Purpose

    Arnica Montana 6C HPUS* .....Anti-inflammatory

  • Uses

    For the temporary relief of sore muscles, bruises, sprains

    Product uses are based on Homeopathic Materia Medica not clinical tests. This product has not been clinically tested by Nartex Labs USA, Inc.

  • Warnings

    Do not use if you have an allergy or hypersensitivity to the components of the fourmal or have had a prior reaction to this product.

  • ASK DOCTOR

    Stop use and ask a physcian if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • rash develops.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, consult a health professional before use.

  • 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.

  • Directions

    • Adults and children 4 yers of age and older: take 2 tablets every 6 hours, slowly dissolving in the mouth
    • Children under 4 years of age: consult a physician
  • Other Information

    Store in a cool and dry place.

  • Inactive Ingredients

    Gelatin, Lactose, Magnesium stearate, Potato stach, Talc

  • Questions or Comments?

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

  • SPL UNCLASSIFIED SECTION

    Product of Mexico / Producto de Mexico

    Distributed by: Nartex Labs, USA, Inc.

    11711 Memorial Drive #685 Houston, TX 77024

    www.nartexlabsusa.com

  • Arnica Treatment Pack - Arnica Recovery Cream

  • Drug Facts

  • Active Ingredients

    Each does contains equial parts of:

    Anrica Montana TINC HPUS*

    Hamamelis virginiana TINC HPUS*

  • 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. Product uses are based on Homeopathic Materia Medica not clinical tests.

  • Warnings

    For external use only.

    Do not

    • Apply to wounds tor damaged skin
    • apply over large areas of the body
  • WHEN USING

    When using this product

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

    Stop use and ask a doctor if

    • symptoms persist for more than 7 das or clear up and occur again within a few days
    • rash develops
  • PREGNANCY OR BREAST FEEDING

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

  • 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.

  • Directions

    • Adults and children over 2 years of age: apply generously rubbing into affected area as needed
    • children 2 years of age: consult a physcian
  • Other Information

    Store at room temperature

  • 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.

  • SPL UNCLASSIFIED SECTION

    Active Ingredients are prepared in accordance with the Homeopathic Pharmaocopoeia of the United States, and are therefore non-toxic and have no known side effects.

    There is no scientific evidence that the product works. Product's claims are baed only on theories of homeopathy from the 1700's that are not accepted by most modern medical experts.

  • Principal Display Panel

    Arnica Montana KitHOMEOPATHIC

    Arnica Nartex

    for sore muscles and bruises

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

    COMBO PACK

    There is no scientific evidence that the product works. Product's claims are based only on theories of homeopathy from the 1700's that are not accepted by most modern medical experts.

    Contains

    1 tube Net. Wt. 1.05oz (29.7g) and 1 Box 60 tablets

  • INGREDIENTS AND APPEARANCE
    ARNICA TREATMENT PACK 
    arnica treatment pack kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34666-020
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34666-020-011 in 1 KIT; Type 1: Convenience Kit of Co-Package04/11/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 160 BOX 60 
    Part 2 2   in 2 
    Part 1 of 2
    ARNICA RECOVERY 
    arnica recovery tablets tablet
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    TALC (UNII: 7SEV7J4R1U)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (white) Scorescore with uneven pieces
    ShapeROUND ((tablet)) Size10mm
    FlavorImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 BOX; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/11/2019
    Part 2 of 2
    ARNICA RECOVERY 
    arnica recovery cream cream
    Product Information
    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 g
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) (HAMAMELIS VIRGINIANA LEAF - UNII:T07U1161SV) HAMAMELIS VIRGINIANA LEAF1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Product Characteristics
    ColorwhiteScore    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/11/2019
    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(34666-020)