SPL v3
SPL
SPL Set ID 43852cfb-6d28-e54f-e063-6394a90aa090
Route
TOPICAL
Published
Effective Date 2025-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Water Petrolatum Stearic Acid Glycerin Glyceryl Monostearate Cetostearyl Alcohol Mineral Oil Ethylparaben

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-14

Description

Clotrimazole 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Dosage and Administration

1

Description

Clotrimazole 1%

Uses

cures most athlete's foot, jock itch and ringworm

relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Section 51945-4

Warnings

For external use only

Do not use on children under 2 years of age unless directed by a doctor.

When using this product

avoid contact with eyes.

Directions

When practical, clean area with mild soap and warm water and rinse thoroughly. Geny dry by pating or bloting with toiet tissue or soft clotibefore applying. Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.

Chidren under i2 years of age:Consult a doctor

Active Ingredient

Clotrimazole 1%

Other Information

store between 20° - 25°C (68° - 77°F)

see carton or tube crimp for lot number and expiration date

Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Monostearate,Polyoxyl lauryl ether, Mineral Oil, Stearic acid, Glycerin EthylParaben, Petrolatum, Purified water

Stop Use and Ask A Doctor If

irritation occurs

there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

Do not use for diaper rash

Keep Out of Reach of Children

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


Structured Label Content

Uses

cures most athlete's foot, jock itch and ringworm

relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Dosage and Administration (34068-7)

1

Section 51945-4 (51945-4)

Purpose

Antifungal

Warnings

For external use only

Do not use on children under 2 years of age unless directed by a doctor.

When using this product

avoid contact with eyes.

Directions

When practical, clean area with mild soap and warm water and rinse thoroughly. Geny dry by pating or bloting with toiet tissue or soft clotibefore applying. Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.

Chidren under i2 years of age:Consult a doctor

Active Ingredient

Clotrimazole 1%

Other Information (Other information)

store between 20° - 25°C (68° - 77°F)

see carton or tube crimp for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

Cetostearyl Alcohol, Glyceryl Monostearate,Polyoxyl lauryl ether, Mineral Oil, Stearic acid, Glycerin EthylParaben, Petrolatum, Purified water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation occurs

there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

Do not use for diaper rash

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.


Advanced Ingredient Data


Raw Label Data

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