OTC - ACTIVE INGREDIENT SECTION
Active Ingredient Purpose
Undecylenic Acid 3%........................Anti-fungal
OTC - PURPOSE SECTION
Anti-fungal
Active Ingredient Purpose
Undecylenic Acid 3%........................Anti-fungal
Anti-fungal
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.
When using this product avoid contact with eyes.
Stop use and ask a doctor if irritation occurs.
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.
Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax
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
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1437982 | Fiore Rx Antifungal 3 % Nail Polish | PSN | 2 |
| 1437977 | Undecylenic Acid 3 % Topical Solution | PSN | 2 |
| 1437982 | undecylenic acid 30 MG/ML Topical Solution [Fiore] | SBD | 2 |
| 1437977 | undecylenic acid 30 MG/ML Topical Solution | SCD | 2 |
| 1437982 | Fiore 30 MG/ML Topical Solution | SY | 2 |
| 1437982 | Fiore Rx 3 % Nail Polish | SY | 2 |
| 1437977 | Undecylenic Acid 3 % Topical Solution | SY | 2 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52261-0204-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-db88-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52261-0204-0 | Fiore Rx Pixie Dust Pink Antifungal Nail Polish | 15 mL in 1 BOTTLE, WITH APPLICATOR | FILM | 15 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52261-0204 | FIORE RX PIXIE DUST PINK ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.] | 2 | Legacy NDC, 1 package rows | 20130920_c26c84c5-af2f-4587-ab3b-3f405493c991.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Undecylenic Acid | ACTIVE INGREDIENT | K3D86KJ24N | 2 | |
| Undecylenic Acid | ACTIVE MOIETY | K3D86KJ24N | 2 | |
| Acetyltributyl Citrate | INACTIVE INGREDIENT | 0ZBX0N59RZ | 2 | |
| Bentoquatam | INACTIVE INGREDIENT | 7F465U79Q1 | 2 | |
| Benzoresorcinol | INACTIVE INGREDIENT | LJ54R4Z029 | 2 | |
| Butyl Acetate | INACTIVE INGREDIENT | 464P5N1905 | 2 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | 2 | |
| D&C RED NO. 34 | INACTIVE INGREDIENT | BAN556989E | 2 | |
| D&C RED NO. 6 | INACTIVE INGREDIENT | 481744AI4O | 2 | |
| DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | INACTIVE INGREDIENT | 905HNO1SIH | 2 | |
| Ethyl Acetate | INACTIVE INGREDIENT | 76845O8NMZ | 2 | |
| Isopropyl Alcohol | INACTIVE INGREDIENT | ND2M416302 | 2 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 2 | |
| POLYESTER-10 | INACTIVE INGREDIENT | 212N9O2MMZ | 2 | |
| PROPOLIS WAX | INACTIVE INGREDIENT | 6Y8XYV2NOF | 2 | |
| Pyroxylin | INACTIVE INGREDIENT | KYR8BR2X6O | 2 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| STANNIC OXIDE | INACTIVE INGREDIENT | KM7N50LOS6 | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| Trimethylpentanediyl Dibenzoate | INACTIVE INGREDIENT | Y8PB83G67A | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52261-0204 | 52261-0204-0 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| Acetyltributyl Citrate | ACETYLTRIBUTYL CITRATE | 0ZBX0N59RZ | TABLET / ORAL | 150 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| Ethyl Acetate | ETHYL ACETATE | 76845O8NMZ | CAPSULE, EXTENDED RELEASE / ORAL | 382.26 mg | ||
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | ND2M416302 | LOTION, AUGMENTED / TOPICAL | 2070 mg | ||
| DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | 905HNO1SIH | SUSPENSION / ORAL | 255 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| Acetyltributyl Citrate | ACETYLTRIBUTYL CITRATE | 0ZBX0N59RZ | CAPSULE, COATED / ORAL | 11 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| BUTYL ALCOHOL | BUTYL ALCOHOL | 8PJ61P6TS3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | 905HNO1SIH | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| Acetyltributyl Citrate | ACETYLTRIBUTYL CITRATE | 0ZBX0N59RZ | SOLUTION / TOPICAL | 5.4 %w/w | ||
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | ND2M416302 | GEL, METERED / TOPICAL | 525 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| BUTYL ALCOHOL | BUTYL ALCOHOL | 8PJ61P6TS3 | TABLET / ORAL | 0.01 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | ND2M416302 | SOLUTION / TOPICAL | 40 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| BUTYL ALCOHOL | BUTYL ALCOHOL | 8PJ61P6TS3 | SOLUTION / TOPICAL | 0.08 %w/w | ||
| DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | 905HNO1SIH | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| Acetyltributyl Citrate | ACETYLTRIBUTYL CITRATE | 0ZBX0N59RZ | CAPSULE / ORAL | 7 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| BUTYL ALCOHOL | BUTYL ALCOHOL | 8PJ61P6TS3 | TABLET, DELAYED RELEASE / ORAL | 0.05 mg | ||
| DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | 905HNO1SIH | SYSTEM / TRANSDERMAL | 18 mg | ||
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | ND2M416302 | GEL / TOPICAL | 75 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | 905HNO1SIH | TABLET, ORALLY DISINTEGRATING / ORAL | 222 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| BUTYL ALCOHOL | BUTYL ALCOHOL | 8PJ61P6TS3 | CAPSULE / ORAL | 0.02 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | 905HNO1SIH | TABLET, FILM COATED / ORAL | 100 mg | ||
| DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | 905HNO1SIH | GRANULE / ORAL | 229 mg | ||
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | ND2M416302 | SWAB / TOPICAL | 43.9 %w/w | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e472d4a8-1150-4b38-a370-83f4c0fdf5d5 | c26c84c5-af2f-4587-ab3b-3f405493c991 | 2013-09-19 | Warnings | e472d4a8-1150-4b38-a370-83f4c0fdf5d5 c26c84c5-af2f-4587-ab3b-3f405493c991 |
Adverse event summaries are temporarily unavailable. Other product information remains available.