Vite20 Liquid
FDA Label NDC 63347-810

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blaine Labs Inc. for the product Vite20 (NDC 63347-810). 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 drug factsactive ingredient, purpose, keep out of reach of children., indications, warnings, when using this product, stop use and consult a physician, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Keep Out Of Reach Of Children.

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

Indications

  • 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

  • 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

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

Stop Use And Consult A Physician

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

  • 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

  • Store at room temperature

Inactive Ingredients

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

Vite20 Product Label

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

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