Otc - Active Ingredient
Active Ingredient Purpose
Undecylenic Acid 3%........................Anti-fungal
Fiore Rx Antifungal Nail Lacquer Red Velvet Cake
FDA Label NDC 52261-0201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosco International, Inc. for the product Fiore Rx Antifungal Nail Lacquer Red Velvet Cake (NDC 52261-0201). 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 otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, indications & usage, directions, inactive ingredients:, may contain:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anti-fungal
Warnings
Warnings For external use only.
Otc - Keep Out Of Reach Of Children
Do not use on children under 2 years of age unless directed by a doctor.
KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.In case of accidental ingestion, contact a physician, emergency medical care facility or poison control center immediately for advice.
Indications & Usage
When using this product avoid contact with eyes.
Stop use and ask a doctor if irritation occurs.
Directions
Clean nails and dry thoroughly.
Remove any nail polish with nail
polish remover. Allow to dry
thoroughly. Roll your bottle of Fioré
Rx Antifungal Nail Lacquer in between
your hands to mix the lacquer
thoroughly. Do not shake the bottle,
as this can introduce air bubbles that
will affect the quality of the lacquer.
Using only the brush provided in the
Fioré Rx bottle, apply a strip of
lacquer down the middle of your nail
from cuticle to tip before following it
with lacquer on either side. Allow
lacquer to dry for at least 2 minutes.
For best results, apply a second coat
and allow to dry for 30 minutes.
Inactive Ingredients:
Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic anhydride copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax
May Contain:
CI 60725, Benzophenone-3,
Bensophenone-1, Acrylates Copolymer,
Stearalkonium Bentonite, CI 15880, CI
15850, Silica, N-Butyl Alcohol, CI
15850:1, CI 77891,
Trimethylpentanediyl Dibenzoate,
Styrene Acrylates Copolymer,Mica, Tin
Oxide, CI 77510, CI 19140, CI 77491
Package Label.Principal Display Panel
Fiore Rx Drug Facts Label.jpg (Mm1)
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