Vite20

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 00:48:37

Label at a glance#

ProductVite20
Active ingredientMICONAZOLE NITRATE
Label structure11 sections

Dosage and administration

Was the affected area with soap and water, dry thorougly, then apply sparingly over the affected area. Use twice daily (morning and night) or as directed by a physician Supervise children in the use of this product For Athlete's Foot and Ringworm, use daily for four (4) weeks. For Jock Itch, use daily for two (2) weeks. If condition persists longer, consult a physician Wash hands after each use.

Label contents#

Full prescribing information#

DRUG FACTSActive Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

INDICATIONS

INDICATIONS & USAGE SECTION

  • Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis)
  • Relieves Itching, cracking, burning and scaling.  which accompany these conditions
  • Prevents most Athlete's Foot with daily use

WARNINGS

WARNINGS SECTION

  • For external use only
  • Do not use :
  •    On children under two (2) years of age unless directed by a physician
  • In or near the mouth or the eyes
  • For vaginal yeast infections

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

Stop use and consult a physician

OTC - STOP USE SECTION

if irritation occurs or if there is no improvement within four (4) weeks (for Athlete's Foot or Ringworm) or within two (2) weeks (for Jock Itch)

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Was the affected area with soap and water, dry thorougly, then apply sparingly over the affected area. Use twice daily (morning and night) or as directed by a physician
  • Supervise children in the use of this product
  • For Athlete's Foot and Ringworm, use daily for four (4) weeks. For Jock Itch, use daily for two (2) weeks. If condition persists longer, consult a physician
  • Wash hands after each use.

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Isopropyl Alcohol, Deionized Water, Triethanokamine, Glycerin, Hydroxypropylcelluose, Tocopheryl Acetate, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben, Phenoxyethanol

Vite20 product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VITÉ 20

BRUSH - ON

NDC# 63347-810-01

Vité20®

BRUSH-ON

KILLS FUNGUS

Maxium Strength

Professional Formula

15 mL (0.5 FL OZ)

SEE SIDE PANEL FOR MORE INFORMATION

KILLS FUNGUS

*Made in the U.S.A.

Questions or Comments?

Call 800-307-8818 M-F

7:00 am - 5:00 pm PST

www.vite20.com

Manufactured by:

Blaine Labs, Inc.

11037 Lockport Place

Santa Fe Springs, CA 90670

Please recycle!

This package is made from recyclable materials

06100-p-bx01

Vite20 - 810Vite20 - 810

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998525miconazole nitrate 2 % Topical SolutionPSN5
998525miconazole nitrate 20 MG/ML Topical SolutionSCD5
998525miconazole nitrate 2 % Topical SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63347-810-012022-02-21C16284748780-1d6a99b39-5041-a426-e053-dadaa90af4c2Vite20 - 810
63347-810-012022-01-28C16284748780-1d6a99b39-5041-a426-e053-dadaa90af4c2Vite20 - 810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63347-810-01Vite201 in 1 BOXLIQUID15
63347-810-01Vite2015 mL in 1 BOTTLELIQUID155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63347-810VITE20 (MICONAZOLE NITRATE) LIQUID [BLAINE LABS INC.]5Current NDC, Legacy NDC, 2 package rows20241226_28a8d0dd-aab9-44ff-bab6-7ec4b5036a71.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63347-81063347-810-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

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
Vite20MICONAZOLE NITRATEBlaine Labs Inc.28a8d0dd-aab9-44ff-bab6-7ec4b5036a712024-12-24WarningsExact identifier
ndc (package): 63347-810-01
ndc (product): 63347-810
ndc11 (package): 63347081001
spl id: 27a77fc1-4426-4d60-822b-3d85a0560f13
spl set id: 28a8d0dd-aab9-44ff-bab6-7ec4b5036a71

Reported adverse events (FAERS/openFDA)#

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