Premier Value® Maximum Strength Antifungal Liquid Solution

Manufacturer
PHARMACY VALUE ALLIANCE, LLC
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:31:27

Label at a glance#

ProductPremier Value Antifungal Maximum Strength
Active ingredientUNDECYLENIC ACID
Label structure9 sections

Indications and 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.

Dosage and administration

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, ventil...

Label contents#

Full prescribing information#

​Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

​Purpose

OTC - PURPOSE SECTION

Anti-fungal

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Ask a doctor before use

OTC - ASK DOCTOR SECTION

On children under 2 years of age

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

​Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

Isopropyl palmitate

Questions?

OTC - QUESTIONS SECTION

Call 1-866-467-2748

Principal Display Panel

PACKAGE LABEL.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 Fungi Cure®

Premier Value Max Str Anti Fungal Liquid
Premier Value Max Str Anti Fungal Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-474-00Premier Value AntifungalMaximum Strength30 mL in 1 BOTTLE, WITH APPLICATORLIQUID306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-474PREMIER VALUE ANTIFUNGAL MAXIMUM STRENGTH (UNDECYLENIC ACID) LIQUID [PHARMACY VALUE ALLIANCE, LLC]6Current NDC, Legacy NDC, 1 package rows20241030_f5694ee5-616c-40f6-8da4-c3620dbcd6f7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-474-00ML - Milliliter68016-474230bf601-f1d0-469d-81e8-afd04c64b3fb12022-06-06

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-47468016-474-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
UNDECYLENIC ACIDK3D86KJ24NACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT

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
Premier Value Antifungal Maximum StrengthUNDECYLENIC ACIDPHARMACY VALUE ALLIANCE, LLCf5694ee5-616c-40f6-8da4-c3620dbcd6f72024-10-28WarningsExact identifier
ndc (package): 68016-474-00
ndc (product): 68016-474
ndc11 (package): 68016047400
spl id: 49f1dae5-2b13-47e8-9a1a-cf6cbf834400
spl set id: f5694ee5-616c-40f6-8da4-c3620dbcd6f7

Reported adverse events (FAERS/openFDA)#

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