Label: TRIVAL- homeopathic alopecia areata treatment tincture

  • 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 22, 2009

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

  • PRINCIPAL DISPLAY PANEL

    image of box front label


    NDC: 49998-332-16
    Trival
    Homeopathic Alopecia Areata Treatment
    For Hair Loss
    1.69 FL. OZ.
  • DESCRIPTION

    image of box back label


    Distributed By:
    TRIVAL LLC
    44598 Bayview Ave #12311
    Clinton Twp., MI 48038
    Lot Number:

    Manufactured By:
    TE-Point Doo
    Tetovo, Macedonia
    Made in Macedonia
    Expiration Date:

    Drug Facts
    Active Ingredients                                                  Purpose
    Dwarf Nettle (urtica urens) 1C HPUS . . . . . . . . . . . Stimulates hair growth
    European beech nut (fagus sylvatica) 1C HPUS . . . Stimulates hair growth
    Garlic (allium sativum) 1C HPUS . . . . . . . . . . . . . . Disinfection
    Olive flower (olea europaea flos) 1C HPUS . . . . . . . Disinfection
    St. John's Wort (hypericum perforatum) 2C HPUS . . Disinfection
    Woodland strawberry (fragaria vesca) 1C HPUS . . .  Stimulates hair growth

    The letters 'HPUS' indicate that these ingredients are officially included in the Homeopathic Pharmacopeia of the United States.

    Uses
    Treats hair loss (alopecia areata) on the scalp, beard, and eyebrows.
    Relieves scalp from redness, itching and dandruff.
    To be used according to standard Homeopathic conditions.

    Warnings
    For external use only
    If pregnant or breast feeding, ask a health professional before use.
    Keep out of reach of children.
    Before using, ask your doctor: If you have any known allergies to the ingredients in this product; if you have had or will be having any medical condition(s) and/or procedure(s) relating to skin or scalp.
    Avoid getting into eyes.  If contact occurs, rinse with flowing water.

    When using this product you may experience mild itching sensation.

    Directions
    Only to be used by adults and children 12 years and older
    Apply at night before bed
    Pour sufficient amount into hands to cover entire scalp
    Massage into scalp with hands
    Rinse the next morning
    Repeat procedure over the next two consecutive nights
    Wait 10-15 days to see results
    If no results, wait 30 days before next application
    See insert for more detailed instructions

    Other information
    Store product in a cool, dry place.
    Do not use product if seal has been broken
    Contains 2.5% alcohol

    Inactive Ingredients
    Alcohol, Blackberry

    Questions?

    Or to Report Adverse Events, call: TEL: 1-800-897-9830

  • INGREDIENTS AND APPEARANCE
    TRIVAL 
    homeopathic alopecia areata treatment tincture
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49998-332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens1 [hp_C]
    Olea Europaea Flower (UNII: 498M34P1VZ) (Olea Europaea Flower - UNII:498M34P1VZ) Olea Europaea Flower1 [hp_C]
    St. John's Wort (UNII: UFH8805FKA) (St. John's Wort - UNII:UFH8805FKA) St. John's Wort2 [hp_C]
    Fragaria Vesca Fruit (UNII: CG6IX3GCMU) (Fragaria Vesca Fruit - UNII:CG6IX3GCMU) Fragaria Vesca Fruit1 [hp_C]
    Garlic (UNII: V1V998DC17) (Garlic - UNII:V1V998DC17) Garlic1 [hp_C]
    Fagus Sylvatica Nut (UNII: I57ERU2601) (Fagus Sylvatica Nut - UNII:I57ERU2601) Fagus Sylvatica Nut1 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    Blackberry (UNII: 8A6OMU3I8L)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49998-332-161 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/22/2009
    Labeler - TE-Point Doo (565947228)
    Establishment
    NameAddressID/FEIBusiness Operations
    TE-Point Doo565947228manufacture