83818-024 update manufacturer

83818-024 update manufacturer
SPL v2
SPL
SPL Set ID 3db832f4-630d-72a2-e063-6394a90a08dc
Route
topical
Published
Effective Date 2025-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Purpose

Antifungal

Description

Terbinafine hydrochloride 1%


Medication Information

Warnings

For external use only.

Purpose

Antifungal

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.

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%)

Description

Terbinafine hydrochloride 1%

Principal Display Panel

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

Questions

Email: [email protected]

Website: pharmbanners.com

Ask Doctor

• Irritation occurs or gets worse

• Symptoms do not improve after 4 weeks

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%

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

Warnings

For external use only.

Purpose

Antifungal

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.

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)

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

Questions

Email: [email protected]

Website: pharmbanners.com

Ask Doctor

• Irritation occurs or gets worse

• Symptoms do not improve after 4 weeks

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%

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


Raw Label Data

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