Terbinafine Hydrochloride
FDA Label NDC 68016-080

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance Llc for the product Terbinafine Hydrochloride (NDC 68016-080). 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.

Label Section Quick Index

Other

Drug Facts

Distributed By: Pharmacy Value Alliance, LLC
407 East Lancaster Avenue, Wayne, PA 19087

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 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.

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 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 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
1 week between the toes
Figure 1 (Terbinafine 01)

Figure 1 (Terbinafine 01)


2 weeks on the bottom
or sides of the foot
Figure 2 (Terbinafine 02)

Figure 2 (Terbinafine 02)

Other Information

  • do not use if seal on tube is broken or is not visible
  • store at controlled room temperature 20°-25°C (68°-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

Principal Display Panel - 30 G Tube Carton

Premier
Value ®

Athlete's Foot Cream
Terbinafine Hydrochloride Cream 1%

Antifungal Cream

Cures Most Athlete's Foot

NET WT 1 oz (30 g)

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

Principal Display Panel (30 g Tube Carton)

Principal Display Panel (30 g Tube Carton)

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