Premier Value Antifungal Liquid
FDA Label NDC 68016-474

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Premier Value Antifungal (NDC 68016-474). 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 ​active ingredient, ​purpose, uses, warnings, ask a doctor before use, when using this product, stop use and consult a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

​Active Ingredient

Undecylenic Acid 25%

​Purpose

Anti-fungal

Uses

  • ▪For the cure of most:
  • ▪ringworm (tinea corporis)
  • ▪athlete’s foot (tinea pedis)
  • ▪itching
  • ▪scaling
  • ▪cracking
  • ▪burning
  • ▪redness
  • ▪soreness
  • ▪irritation
  • ▪discomfort

    • which may accompany these conditions.

Warnings

For external use only

Ask A Doctor Before Use

On children under 2 years of age

When Using This Product

avoid contact with eyes

Stop Use And Consult A Doctor If

  • ▪irritation occurs
  • ▪there is no improvement within 4 weeks

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control right away at 1-800-222-1222.

​Directions

Read all warnings and directions.

  • ▪Read all package directions and warnings before use
  • ▪Use only as directed
  • ▪clean the affected area with soap and warm water and dry thoroughly
  • ▪Apply a thin layer of this product over affected area twice daily (morning and night) or as directed by a doctor.
  • ▪The brush applicator allows for easy application under nails and surrounding cuticle area.
  • ▪wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • ▪this product is not effective on the scalp or nails
  • ▪for athlete's foot: pay special attention to spaces between 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. If conditions persists longer, consult a doctor
  • ▪Intended for use by normally healthy adults only
  • ▪Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor
  • ▪Supervise children in the use of this product

Other Information

  • This product may be applied to exposed nail-beds to cuticles, around nail edges and under nail tips where reachable with its applicator brush
  • This product is not intended to, nor will it, penetrate hard nail surfaces
  • While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use this product until satisfactory results are obtained.
  • store at room temperature. Keep the container tightly closed when not in use.
  • Store away from excessive heat and cold.

​Inactive Ingredient

Isopropyl palmitate

Questions?

Call 1-866-467-2748

Principal Display Panel

NDC 68016-474-00

COMPARE TO THE ACTIVE INGREDIENT FUNGICURE®

MAXIMUM STRENGTH
Anti-Fungal Liquid

  • Topical formula for toe and foot
  • Cures and Heals athlete’s foot fungus and ringworm
  • Helps relieves related discomforts

    • 1 FL OZ (30mL)

    IMPORTANT: KEEP this carton for future reference on full labeling

    DISTRIBUTED BY

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

    *This product is not manufactured or distributed by ALVA-AMCO Pharmacal Cos., Inc., the distributor of Funji Cure®

* Please review the disclaimer below.