83818-024 Update Manufacturer

Drug Facts

Composition & Product

Active Ingredients

Terbinafine (1 g)

Inactive Ingredients

Sorbitan Monostearate Isopropyl Myristate Urea Cetyl Palmitate Water Stearyl Alcohol Cetyl Alcohol Polysorbate 60 Sodium Hydroxide Panthenol Menthol Benzyl Alcohol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-09-01

Medication Information

Purpose

Antifungal

Description

Terbinafine hydrochloride 1%

Use

• 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

• Also helps relieve symptoms of tinea versicolor (pityriasis versicolor)

Stop Use

• Irritation occurs or gets worse

• Symptoms do not improve after 4 weeks

Warnings

For external use only.

Questions

Email: [email protected]

Website: pharmbanners.com

Ask Doctor

• Irritation occurs or gets worse

• Symptoms do not improve after 4 weeks

Directions

• Adults and children 12 years and older:

- Wash the affected area with soap and water and dry completely before applying.

- Apply a thin layer to affected skin once or twice daily as directed.

- For tinea versicolor: apply once daily for 2 weeks.

- 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

When Using

• Do not get into eyes. If contact occurs, rinse thoroughly with water.

Active Ingredient

Terbinafine hydrochloride 1%

Other Information

• Store at controlled room temperature 20°–25 °C (68°–77 °F).

• Do not use if the seal is broken.

Inactive Ingredients

Purified Water (Aqua), Cetyl Alcohol, Stearyl Alcohol, Cetyl Palmitate, Isopropyl Myristate, Polysorbate 60, Sorbitan Monostearate, Benzyl Alcohol, Sodium Hydroxide, Panthenol(1%), Urea(4%), Menthol(0.5%)

Principal Display Panel

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Structured Label Content

Use

• 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

• Also helps relieve symptoms of tinea versicolor (pityriasis versicolor)

Purpose

Antifungal

Stop Use

• Irritation occurs or gets worse

• Symptoms do not improve after 4 weeks

Warnings

For external use only.

Questions

Email: [email protected]

Website: pharmbanners.com

Ask Doctor

• Irritation occurs or gets worse

• Symptoms do not improve after 4 weeks

Directions

• Adults and children 12 years and older:

- Wash the affected area with soap and water and dry completely before applying.

- Apply a thin layer to affected skin once or twice daily as directed.

- For tinea versicolor: apply once daily for 2 weeks.

- 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

When Using

• Do not get into eyes. If contact occurs, rinse thoroughly with water.

Active Ingredient

Terbinafine hydrochloride 1%

Other Information (Other information)

• Store at controlled room temperature 20°–25 °C (68°–77 °F).

• Do not use if the seal is broken.

Inactive Ingredients (Inactive ingredients)

Purified Water (Aqua), Cetyl Alcohol, Stearyl Alcohol, Cetyl Palmitate, Isopropyl Myristate, Polysorbate 60, Sorbitan Monostearate, Benzyl Alcohol, Sodium Hydroxide, Panthenol(1%), Urea(4%), Menthol(0.5%)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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 (1-800-222-1222).

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "• 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 • Also helps relieve symptoms of tinea versicolor (pityriasis versicolor)", "Purpose": "Antifungal", "Stop Use": "• Irritation occurs or gets worse • Symptoms do not improve after 4 weeks", "Warnings": "For external use only.", "Questions": "Email: cs@pharmbanners.com Website: pharmbanners.com", "Ask Doctor": "• Irritation occurs or gets worse • Symptoms do not improve after 4 weeks", "Directions": "• Adults and children 12 years and older: - Wash the affected area with soap and water and dry completely before applying. - Apply a thin layer to affected skin once or twice daily as directed. - For tinea versicolor: apply once daily for 2 weeks. - 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", "When Using": "• Do not get into eyes. If contact occurs, rinse thoroughly with water.", "Active Ingredient": "Terbinafine hydrochloride 1%", "Other information": "• Store at controlled room temperature 20°–25 °C (68°–77 °F). • Do not use if the seal is broken.", "Inactive ingredients": "Purified Water (Aqua), Cetyl Alcohol, Stearyl Alcohol, Cetyl Palmitate, Isopropyl Myristate, Polysorbate 60, Sorbitan Monostearate, Benzyl Alcohol, Sodium Hydroxide, Panthenol(1%), Urea(4%), Menthol(0.5%)", "Keep Out Of Reach Of Children": "If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)."}

83818-024 Update Manufacturer

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information