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  5. Label Information: Cvs

FDA Label for Cvs

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. OTC - WHEN USING
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PRINCIPAL DISPLAY PANEL - 15 G TUBE CARTON

Cvs Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

* Please review the disclaimer below.