Terbinafine Hydrochloride Cream
FDA Label NDC 85766-309

14 label sections · Submitted to the FDA by Sportpharm Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sportpharm Llc for the product Terbinafine Hydrochloride (NDC 85766-309). 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, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Distributed by:

Sportpharm LLC

379 Van Ness Ave 1401,

Torrance, CA 90501

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

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 productdo not get into eyes. If eye contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor iftoo 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 footwear 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 weekor as directed by a doctor
      • on the bottom or sides of the foot:
        apply twice a day (morning and night) for 2 weeksor as directed by a doctor
      • for jock itch and ringworm:
        apply once a day (morning ornight) for 1 weekor 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
Image (Terbinafine 02)

Image (Terbinafine 02)

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

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