Cvs Pharmacy
FDA Label NDC 59779-965

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Pharmacy (NDC 59779-965). 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, otc - ask doctor, otc - do not use, otc - when using, otc - stop use, 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)

    • For the relief of:

    • itching
    • scaling
    • crackling
    • burning
    • redness
    • soreness
    • irritation and discomfort which may accompany these conditions

Warnings

For external use only

Otc - Ask Doctor

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

Otc - Do Not Use

Do not use on diaper rash

Otc - When Using

When using this product avoid contact with the eyes

Otc - Stop Use

Stop use and ask doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Otc - 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.

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
  • twist the base of the 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; 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 condition 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
  • this product is not effective on the scalp or nails

Other Information

  • Store at 15°-30C° (59°-86°F)
  • Keep cap on pen when not in use

Inactive Ingredients

Isopropyl Palmitate, Propylparaben

Questions Or Comments?

1-800-526-FOOT (3668) Mon-Fri 9AM - 5 PM EST

Image Of Label And Carton

CVSAntifungalPenLabel.jpg

Label (Cvsantifungalpenlabel)

Label (Cvsantifungalpenlabel)

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