CVS Maximum Strength Anti-Fungal Pen 25%

Manufacturer
Denison Pharmaceuticals, LLC
Effective date
2019-01-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:34:19

Label at a glance#

ProductCVS Maximum Strength Anti-Fungal Pen 25%
Active ingredientUNDECYLENIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Undecylenic acid 25%

OTC - PURPOSE SECTION

Purpose

Anti-fungal

INDICATIONS & USAGE SECTION

Uses

For the cure of most

  • ringworm (tinea capitis)
  • athlete's foot (tinea pedis)

For the relief of:

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation and discomforts which may accompany these conditions

WARNINGS SECTION

Warnings

For external use only

Ask a doctor before use on children under 2 years of age

When using this product avoid contact with the eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • read all warnings and directions
  • use only as directed
  • clean the affected area with soap and water and dry thoroughly
  • remove cap from pen, with brush pointing downward, until product dispenses
  • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor
  • for athlete's foot, pay special attention to spaces between the toes; 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 condition persists longer, consult a doctor.
  • supervise children in the use of this product
  • this product is not effective on the scalp or nails

OTHER SAFETY INFORMATION

Other information

  • Store at 15 o - 30 oC (59 o - 86 oF)
  • Keep cap on pen when not in use

INACTIVE INGREDIENT SECTION

Inactive ingredient

Isopropyl Palmitate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Products#

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-90080295-9008-16

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
ISOPROPYL PALMITATE8CRQ2TH63MIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB

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
07806e4b-9123-a533-e063-6394a90a16fc7ee60b49-f12f-a0e1-e053-2991aa0a356e2023-10-12WarningsExact identifier
spl set id: 7ee60b49-f12f-a0e1-e053-2991aa0a356e

Reported adverse events (FAERS/openFDA)#

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