Vite20 - Blaine Labs Inc.

Manufacturer
Blaine Labs Inc.
Effective date
2024-12-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:48:36

Label at a glance#

ProductVite20
Active ingredientUNDECYLENIC ACID
Label structure8 sections

Indications and uses

USOS: Cura el pie de (tinea pedis), comezon en la ingle (tinea cruris) y tina (tinea corporis). Par alivio effectivo de la comezon, agrietamiento, ardor y molestias asociadas con estas enfermedades. USES:Cures athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm(tinea corpois). For effective relief of itching, cracking, burning and discomfort that can accompany these conditions.

Dosage and administration

MODO DE EMPLEO: Lave con aqua y jabon ;as areas afectadas y sequelas adecuadamente. Aplique una capa ligera dos veces al dia (manana y noche), o como lo haya indicado su medico. Los ninos menores de 12 anos que usen este producto deberan hacerlo bajo estricta supervision de un adulto. En los casos de pie de atleta, debe poner atencion entre los dedos de los pies. Es recomendable que use zapatos a la medida y bien ...

Label contents#

Full prescribing information#

Ingrediente Activo Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

INGREDIENTE ACTIVO: Acido Undecilenico 10 %

Active Ingredient: Undecylenic Acid 10%

Purpose

OTC - PURPOSE SECTION

CREMA ANTIHONGOS

Antifungal Cream

Precauciones Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Mantenga este y todos los medicamentos fuera del alcance de los ninos. En caso de ingestion accidental, comuniquese con el centro de salud mas cercano y pida ayuda profesional inmediatamente.

Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Usos USES

INDICATIONS & USAGE SECTION

USOS: Cura el pie de (tinea pedis), comezon en la ingle (tinea cruris) y tina (tinea corporis). Par alivio effectivo de la comezon, agrietamiento, ardor y molestias asociadas con estas enfermedades.

USES:Cures athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm(tinea corpois). For effective relief of itching, cracking, burning and discomfort that can accompany these conditions.

Precauciones Warnings

WARNINGS SECTION

PRECAUCIONES: No debe aplicarse en menores de 2 anos, excepto cuando su medico lo recomiende. Para uso externo unicamente. Evite el contacto con los olos. Si observa alguna irritacion, o si no hay mejoria despues de cuatro semanas (en el pie de atleta o en la tina), o dos semanas (en la comezon el la ingle), suspenda su uso y consulte a su medico. Mantenga este y todos los medicamentos fuera del alcance de los ninos. En caso de ingestion accidental, comuniquese con el centro de salud mas cercano y pida ayuda profesional inmediatamente.

WARNINGS: Do not use on children under 2 years of age unless directed by a physician. For external use only. Avoid contact with eyes. If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a physician. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Modo De Empleo Directions

DOSAGE & ADMINISTRATION SECTION

MODO DE EMPLEO: Lave con aqua y jabon ;as areas afectadas y sequelas adecuadamente. Aplique una capa ligera dos veces al dia (manana y noche), o como lo haya indicado su medico. Los ninos menores de 12 anos que usen este producto deberan hacerlo bajo estricta supervision de un adulto. En los casos de pie de atleta, debe poner atencion entre los dedos de los pies. Es recomendable que use zapatos a la medida y bien ventilados, y cambiarse de calcentines y zapatos cuando menos una vez al dia. Para el pie de atleta y la tina, use diario por cuatro semanas; papa comezon en la ingle, does semanas son suficentes. Si no obtiene resultados en el tiemp indicado, es mejor consultar con su medico.

DIRECTIONS: wash the affected area with soap and water and dry thoroughly. Apply sparingly over affected area twice daily (morning and night), or as directed by a physician. For athlete's foot, pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a physician. This product is not effective on scalp or nails. Supervise children in the use of this product.

Otros Ingredientes Inactive Ingredients

INACTIVE INGREDIENT SECTION

OTROS INGREDIENTES: Savila, Alcohol Cetilico, Clotrimazole, Caprilate de Coco, Acido Etilendiamino Tetraacetico, Estearato de Glicerilo, Celulosa Hidroxilada, Aceite de Lavanda. Metilparabeno, Polietileno de Glicol de Estearato 100, Polisorbato 60, Propilparabeno, Acido Estearico, Melaleuca, Trietanolamina, Urea, Agua.

INACTIVE INGREDIENTS: Aloe Vera, Cetyl Alcohol, Clotrimazole, Coco-Caprylate/Caprate, Disodium EDTA, Glyceryl Stearic, Hydroxyethylcellulose, lavender Oil, Methylparaben, PEG-100 Stearate, Polysorbate 60, Propylparaben, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, Water.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VITE20   CREMA ANIHONGOS

Cont. Neto 20 ml

para manos y pies saludables

Blaine labs, Inc. Santa Fe Springs, CA 90670, U.S.A.   (800) 307-8818    PNE-V20AR Rev. 20120229

Blaine Vite20 LabelBlaine Vite20 Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63347-800-012022-02-21C16284748780-1d6a99b39-37f8-a426-e053-dadaa90af4c218f8ea1c-360e-43c0-98df-5816af4dec66
63347-800-012022-01-28C16284748780-1d6a99b39-37f8-a426-e053-dadaa90af4c218f8ea1c-360e-43c0-98df-5816af4dec66

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63347-800-01Vite2020 mL in 1 TUBECREAM205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63347-800VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]5Current NDC, Legacy NDC, 1 package rows20241226_18f8ea1c-360e-43c0-98df-5816af4dec66.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
UNDECYLENIC ACIDACTIVE INGREDIENTK3D86KJ24N1
UNDECYLENIC ACIDACTIVE MOIETYK3D86KJ24N1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CLOTRIMAZOLEINACTIVE INGREDIENTG07GZ97H651
COCO-CAPRYLATEINACTIVE INGREDIENT4828G836N61
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%)INACTIVE INGREDIENTX70SE62ZAR1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
UREAINACTIVE INGREDIENT8W8T17847W1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63347-80063347-800-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

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.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
UREAUREA8W8T17847WSYSTEM / TOPICAL840 mgExact identifier — unii+route
4 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii+route
2 equally ranked IID candidates
UREAUREA8W8T17847WCREAM / VAGINAL0.64 %w/wExact identifier — unii+dosage form
4 equally ranked IID candidates
UREAUREA8W8T17847WCREAM / VAGINAL0.64 %w/wExact identifier — unii+dosage form
4 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii+route
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
UREAUREA8W8T17847WSYSTEM / TOPICAL840 mgExact identifier — unii+route
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vite20UNDECYLENIC ACIDBlaine Labs Inc.18f8ea1c-360e-43c0-98df-5816af4dec662024-12-24WarningsExact identifier
ndc (package): 63347-800-01
ndc (product): 63347-800
ndc11 (package): 63347080001
spl id: d6d98f0f-58dd-4fb8-9403-5ce47b071e29
spl set id: 18f8ea1c-360e-43c0-98df-5816af4dec66

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.