Label: ARNICA MONTANA NARTEX gel

  • NDC Code(s): 34666-281-30, 34666-281-60, 34666-281-90
  • 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 12, 2019

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

View All Sections
  • Drug Facts

  • Active Ingredients

    Arnica TINC HPUS*

    Bellis 3X HPUS*

    Calendula HPUS*

    Chamomila 3X HPUS*

    Hamamelis 3x HPUS*

  • Purpose

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

    Bellis 3X HPUS*.....................Sprains and Bruises

    Calendula HPUS*..................Pain Relief

    Chamomila 3X HPUS*..........Anti-inflammatory

    Hamamelis 3x 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 and X are homeopathic dilutions. See www.nartexlabsusa.com for more information.

  • Uses

    For the temporary relief of:

    • sore muscles
    • bruises
    • sprains
    • minor burns
    • insect bites

    Indications are based on homeopathic materia medica, not clnical tests.

  • Warnings

    For External Use only

  • DO NOT USE

    Do not:

    • apply to open wounds
    • apply over large areas of the body
  • WHEN USING

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly or use with a heating pad
  • STOP USE

    Stop use and ask doctor if:

    • symptoms persis 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 swalled, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and Children over 4 years of age: apply and gently massage the affected area every 4 hours.

  • Other Information

    • Store at room temperature
    • Do not use if the safety seal of container is broken or missing.
  • Inactive Ingredients

    Aler Vera (Aloe barbadensis Miller) leaf powder, citric acid, glycerin, menthol, methylparaben sodium, propylene glycol, propylparaben sodium, purified water, xanthan gum

  • Questions or Comments?

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

  • SPL UNCLASSIFIED SECTION

    There is no scientific evidence that the product works.

    Product's claims are based only on theories of homepathy from the 1700's that are not accepted by most modern medical experts.

    Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and have no known side effects.

    Product of Mexico / Producto de Mexico

    Distributed by:

    Nartex Labs USA, inc

    11711 Memorial Dr. # 685

    Houston TX, 77024

    www.nartexlabsusa.com

  • PRINCIPAL DISPLAY PANEL

    Arnica Roll On (60g)HOMEOPATHIC

    ARNICA

    MONTANA NARTEX

    ROLL-ON GEL

    For the temporary relief of:

    sore muscles, bruises, sprains, minor burns and insect bites.

    Net Wt. 2.11 oz (60 g)

  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA NARTEX 
    arnica montana nartex gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34666-281
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS3 [hp_X]
    CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) (CALENDULA OFFICINALIS WHOLE - UNII:PFR03EBU0H) CALENDULA OFFICINALIS WHOLE1 [hp_X]
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA3 [hp_X]
    HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU) (HAMAMELIS VIRGINIANA WHOLE - UNII:V663Q8TEFU) HAMAMELIS VIRGINIANA WHOLE3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34666-281-601 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/25/2019
    2NDC:34666-281-901 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/25/2019
    3NDC:34666-281-301 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/25/2019
    Labeler - Nartex Laboratorios Homeopaticos SA DE CV (589914576)
    Registrant - Nartex Laboratorios Homeopaticos SA DE CV (589914576)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nartex Laboratories Homeopaticos SA DE CV589914576manufacture(34666-281)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!