Cvs Cream
FDA Label NDC 59779-523

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 (NDC 59779-523). 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 other, active ingredient, purpose, uses, warnings, do not use, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

Active Ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

  • cures most jock itch (tinea cruris)
  • relieves itching, burning, cracking and scaling which accompany this condition

Warnings

For external use only

Do Not Use

  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections

Otc - When Using

When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Stop Use And Ask A Doctor If

  • too much irritation occurs or gets worse.

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

  • adults and children 12 years and older
  • use the tip of the cap to break the seal and open the tube
  • wash the affected skin with soap and water and dry completely before applying
  • for jock itch apply once a day (morning or night) for 1 week or as directed by a doctor
  • wash hands after each use
  • children under 12 years: ask a doctor

Other Information

  • do not use if seal on tube is broken or is not visible
  • store at controlled room temperature 68°-77° F (20°-25°C)
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.

Principal Display Panel - 15 G Tube Carton

CVS
pharmacy™

NDC 59779-523-01

Compare to the active
ingredient in Lamisil AT®*

JOCK ITCH
CREAM
TERBINAFINE HYDROCHLORIDE
CREAM 1% - ANTIFUNGAL

  • Cures most jock itch
  • Relieves itching & burning
  • Full prescription strength

    • Actual Product Size on Back Panel

    NET WT 0.5 OZ (15 g)

    Principal Display Panel (15 g Tube Carton)

    Principal Display Panel (15 g Tube Carton)

* Please review the disclaimer below.