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  5. Label Information: Terbinafine Hydrochloride

FDA Label for Terbinafine Hydrochloride

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. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. HOW SUPPLIED

Terbinafine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. 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: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532


Active Ingredient



Terbinafine hydrochloride 1%


Purpose



Antifungal


Uses



  • cures most athlete's foot (tinea pedis)
  • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany these conditions

Warnings



For external use only


Do Not Use



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

Otc - When Using



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


Otc - Stop Use



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 over:
    • 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 athlete's foot wear well-fitting, ventilated shoes.
      Change shoes and socks at least once daily.
      • between the toes only:
        apply twice a day (morning and night) for 1 week or as directed by a doctor
      • on the bottom or sides of the foot:
        apply twice a day (morning and night) for 2 weeks or as directed by a doctor
      • for jock itch and ringworm:
        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
Image - terbinafine 01

Image - terbinafine 01

1 week between the toes 2 weeks on the bottom or sides of the foot

Other Information



TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.

  • store at controlled room temperature 20° to 25°C (68° to 77°F)
  • 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


Questions?



call 1-866-923-4914


How Supplied



Product: 50090-5810

NDC: 50090-5810-0 30 g in a TUBE / 1 in a CARTON


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