Terbinafine Hydrochloride

Terbinafine Hydrochloride
SPL v6
SPL
SPL Set ID 76f7525d-2005-4da8-a795-50ede6236c68
Route
TOPICAL
Published
Effective Date 2022-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Terbinafine (1 g)
Inactive Ingredients
Benzyl Alcohol Cetyl Alcohol Cetyl Palmitate Isopropyl Myristate Polysorbate 60 Water Sodium Hydroxide Sorbitan Monostearate Stearyl Alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2007-07-02
Description

Drug Facts

Purpose

Antifungal

Medication Information

Purpose

Antifungal

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 50567-7

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

Warnings

For external use only

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



2 weeks on the bottom or sides of the foot
Do Not Use
  • •
    on nails or scalp
  • •
    in or near the mouth or the eyes
  • •
    for vaginal yeast infections
Active Ingredient

Terbinafine hydrochloride 1%

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.

Stop Use and Ask A Doctor If
  • •
    too much irritation occurs or gets worse.
  • •
    side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
Principal Display Panel 30 G Carton

Cures Most Athlete's Foot

Terbinafine Hydrochloride

Cream 1%

Antifungal Cream

Full Prescription Strength

NET WT 1 oz (30 g)

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 50567-7 (50567-7)

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

Purpose

Antifungal

Warnings

For external use only

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



2 weeks on the bottom or sides of the foot
Do Not Use (Do not use)
  • •
    on nails or scalp
  • •
    in or near the mouth or the eyes
  • •
    for vaginal yeast infections
Active Ingredient (Active ingredient)

Terbinafine hydrochloride 1%

Other Information (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 (Inactive ingredients)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • •
    too much irritation occurs or gets worse.
  • •
    side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
Principal Display Panel 30 G Carton (PRINCIPAL DISPLAY PANEL - 30 g Carton)

Cures Most Athlete's Foot

Terbinafine Hydrochloride

Cream 1%

Antifungal Cream

Full Prescription Strength

NET WT 1 oz (30 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:16.737436 · Updated: 2026-03-14T23:00:38.812142