83818-018

83818-018
SPL v1
SPL
SPL Set ID 3a0860b0-346e-7024-e063-6394a90ace81
Route
TOPICAL
Published
Effective Date 2025-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Aqua Lavender Oil Glycerin Menthol Stearic Acid Olive Oil Propylene Glycol Eucalyptus Oil Citric Acid Sorbitol Alpha-tocopherol Coconut Oil Tea Tree Oil Peppermint Oil Clove Oil Palm Oil Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-16

Description

Clotrimazole 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole 1%

Use

■ Relieves and helps prevent recurrence of:

- Athlete's foot (tinea pedis)

- Jock itch (tinea cruris)

- Ringworm (tinea corporis)

■ Helps reduce body odor, acne, itching, eczema, and irritated skin caused by fungi.

Stop Use

if irritation develops or condition worsens

Warnings

For external use only

Questions

Email us: [email protected]

Ask Doctor

if irritation develops or condition worsens

Directions

■ Use daily in bath or shower.

■ Wet skin and work bar soap into a rich lather.

■ Apply thoroughly to affected areas and surrounding skin.

■ Leave lather on skin for 1-2 minutes before rinsing.

■ Rinse well and dry affected area completely.

■ Use once daily for best results.

■ For athlete's foot: pay special attention to the spaces between toes.

■ Change socks, shoes, and linens daily if possible.

Do Not Use

on broken skin or for vaginal yeast infections.

When Using

avoid contact with eyes

Active Ingredient

Clotrimazole 1%

Other Information

■ Store at room temperature, avoid excessive heat and direct sunlight.

■ For best quality, use within 24 months of opening.

Inactive Ingredients

Tea Tree Oil, Eucalyptus Oil, Menthol, Peppermint Oil, Lavender Oil, Clove Oil, Coconut Oil, Palm Oil, Olive Oil, Glycerin, Aqua, Sorbitol, Sodium Hydroxide, Stearic Acid, Propylene Glycol, Tocopherol (Vitamin E), Citric Acid.

Principal Display Panel

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center.


Structured Label Content

Use

■ Relieves and helps prevent recurrence of:

- Athlete's foot (tinea pedis)

- Jock itch (tinea cruris)

- Ringworm (tinea corporis)

■ Helps reduce body odor, acne, itching, eczema, and irritated skin caused by fungi.

Purpose

Antifungal

Stop Use

if irritation develops or condition worsens

Warnings

For external use only

Questions

Email us: [email protected]

Ask Doctor

if irritation develops or condition worsens

Directions

■ Use daily in bath or shower.

■ Wet skin and work bar soap into a rich lather.

■ Apply thoroughly to affected areas and surrounding skin.

■ Leave lather on skin for 1-2 minutes before rinsing.

■ Rinse well and dry affected area completely.

■ Use once daily for best results.

■ For athlete's foot: pay special attention to the spaces between toes.

■ Change socks, shoes, and linens daily if possible.

Do Not Use (Do not use)

on broken skin or for vaginal yeast infections.

When Using

avoid contact with eyes

Active Ingredient

Clotrimazole 1%

Other Information (Other information)

■ Store at room temperature, avoid excessive heat and direct sunlight.

■ For best quality, use within 24 months of opening.

Inactive Ingredients (Inactive ingredients)

Tea Tree Oil, Eucalyptus Oil, Menthol, Peppermint Oil, Lavender Oil, Clove Oil, Coconut Oil, Palm Oil, Olive Oil, Glycerin, Aqua, Sorbitol, Sodium Hydroxide, Stearic Acid, Propylene Glycol, Tocopherol (Vitamin E), Citric Acid.

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.


Advanced Ingredient Data


Raw Label Data

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