Package Label.Principal Display Panel
NDC: 49998-332-16TrivalHomeopathic Alopecia Areata TreatmentFor Hair Loss1.69 FL. OZ.
Trival
FDA Label NDC 49998-332
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Te-point Doo for the product Trival (NDC 49998-332). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding package label.principal display panel, description, otc - active ingredient, indications & usage, general precautions, otc - when using, dosage & administration, safe handling warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Description
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:
Otc - Active Ingredient
Drug FactsActive Ingredients PurposeDwarf Nettle (urtica urens) 1C HPUS . . . . . . . . . . . Stimulates hair growthEuropean beech nut (fagus sylvatica) 1C HPUS . . . Stimulates hair growthGarlic (allium sativum) 1C HPUS . . . . . . . . . . . . . . DisinfectionOlive flower (olea europaea flos) 1C HPUS . . . . . . . DisinfectionSt. John's Wort (hypericum perforatum) 2C HPUS . . DisinfectionWoodland strawberry (fragaria vesca) 1C HPUS . . . Stimulates hair growthThe letters 'HPUS' indicate that these ingredients are officially included in the Homeopathic Pharmacopeia of the United States.
Indications & Usage
UsesTreats 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.
General Precautions
WarningsFor external use onlyIf 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.
Otc - When Using
When using this product you may experience mild itching sensation.
Dosage & Administration
DirectionsOnly to be used by adults and children 12 years and olderApply at night before bedPour sufficient amount into hands to cover entire scalpMassage into scalp with handsRinse the next morningRepeat procedure over the next two consecutive nightsWait 10-15 days to see resultsIf no results, wait 30 days before next applicationSee insert for more detailed instructions
Safe Handling Warning
Other informationStore product in a cool, dry place.Do not use product if seal has been brokenContains 2.5% alcohol
Inactive Ingredient
Inactive IngredientsAlcohol, Blackberry
Otc - Questions
Questions?
Or to Report Adverse Events, call: TEL: 1-800-897-9830
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