Terbinafine Hydrochloride

Terbinafine Hydrochloride
SPL v4
SPL
SPL Set ID 2ba1924b-9967-4adb-9061-d023ef44ab3e
Route
TOPICAL
Published
Effective Date 2023-11-01
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

Marketing Status
ANDA Active Since 2023-10-25

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 50566-9

Stop use and ask a doctor iftoo much irritation occurs or gets worse

Section 50567-7

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

Warnings

For external use only

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
Do Not Use
  • on nails or scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections
Questions?

call 1-866-923-4914

Active Ingredient

Terbinafine hydrochloride 1%

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

Principal Display Panel 30 G Tube Carton

Athlete's Foot Cream

TERBINAFINE HYDROCHLORIDE CREAM 1% / ANTIFUNGAL

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 50566-9 (50566-9)

Stop use and ask a doctor iftoo much irritation occurs or gets worse

Section 50567-7 (50567-7)

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

Purpose

Antifungal

Warnings

For external use only

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
Do Not Use (Do not use)
  • on nails or scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections
Questions?

call 1-866-923-4914

Active Ingredient (Active ingredient)

Terbinafine hydrochloride 1%

Other Information (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 (Inactive ingredients)

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

Principal Display Panel 30 G Tube Carton (PRINCIPAL DISPLAY PANEL - 30 g Tube Carton)

Athlete's Foot Cream

TERBINAFINE HYDROCHLORIDE CREAM 1% / ANTIFUNGAL

NET WT 1 OZ (30 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)