SPL v1
SPL
SPL Set ID 453452a7-c613-6111-e063-6294a90aca81
Route
TOPICAL
Published
Effective Date 2025-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Bisabolol Stearic Acid Sorbitol Olive Oil Palm Oil Sodium Hydroxide Allantoin Phenoxyethanol Aqua Tea Tree Oil Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-12-04 Until 2026-12-08

Description

Clotrimazole 1%


Medication Information

Warnings and Precautions

For external use only Ask a doctor before use if you have a deep or serious fungal infection. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. If irritation or redness develops, stop use and consult a physician. Keep out of reach of children.

Indications and Usage

Apply soap to wet skin and lather.

Massage gently into affected areas for 30 seconds.

Rinse thoroughly and dry compietely.

Use twice daily or as directed by a healthcare provider.

Dosage and Administration

Massage gently into affected areas for 30 seconds.



Use twice daily or as directed by a healthcare provider.

Description

Clotrimazole 1%

Section 50565-1

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

Section 50566-9

Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.

Section 50567-7

Apply soap to wet skin and lather.

Massage gently into affected areas for 30 seconds.

Rinse thoroughly and dry completely.

Use twice daily or as directed by a healthcare provider.

Section 50570-1

You do not know the reason .

You ae under 18 years of age, Do not use it on babies and children your Skin is red.

You use other medicines on the Skin.Ask a doctor before use if you hace heart disease.

Section 51727-6

Tea Tree Oil, Aqua,Sorbitol,Palm Oil,Coconut Oil Extract, Elaeis Guineensis (palm) Fruit Oil, Coconut Oil Extract,Olive Oil,Propylene Glycol,Ethylhexylglycerin,Stearic Acid,Sorbitol,vitamin E,Allantoin,Ceramide,Sodium Hydroxide,Phenoxyethanol,Bisabolol,Zingiber Officinale (ginger) Root Extract,Witch Hazel Extract,Aloe Vera Extract,Calendula Extract

Section 51945-4

Section 55105-1

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 irritatedd skincaused by fungi

Section 55106-9

Clotrimazole 1%


Structured Label Content

Indications and Usage (34067-9)

Apply soap to wet skin and lather.

Massage gently into affected areas for 30 seconds.

Rinse thoroughly and dry compietely.

Use twice daily or as directed by a healthcare provider.

Dosage and Administration (34068-7)

Massage gently into affected areas for 30 seconds.



Use twice daily or as directed by a healthcare provider.

Warnings and Precautions (34071-1)

For external use only Ask a doctor before use if you have a deep or serious fungal infection. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. If irritation or redness develops, stop use and consult a physician. Keep out of reach of children.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.

Section 50567-7 (50567-7)

Apply soap to wet skin and lather.

Massage gently into affected areas for 30 seconds.

Rinse thoroughly and dry completely.

Use twice daily or as directed by a healthcare provider.

Section 50570-1 (50570-1)

You do not know the reason .

You ae under 18 years of age, Do not use it on babies and children your Skin is red.

You use other medicines on the Skin.Ask a doctor before use if you hace heart disease.

Section 51727-6 (51727-6)

Tea Tree Oil, Aqua,Sorbitol,Palm Oil,Coconut Oil Extract, Elaeis Guineensis (palm) Fruit Oil, Coconut Oil Extract,Olive Oil,Propylene Glycol,Ethylhexylglycerin,Stearic Acid,Sorbitol,vitamin E,Allantoin,Ceramide,Sodium Hydroxide,Phenoxyethanol,Bisabolol,Zingiber Officinale (ginger) Root Extract,Witch Hazel Extract,Aloe Vera Extract,Calendula Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

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 irritatedd skincaused by fungi

Section 55106-9 (55106-9)

Clotrimazole 1%


Advanced Ingredient Data


Raw Label Data

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