initial drug listing - terthon clotrimazole 1% antifungal cream

initial drug listing - terthon clotrimazole 1% antifungal cream
SPL v1
SPL
SPL Set ID 468f1b1b-f67d-8b98-e063-6294a90a7f45
Route
topical
Published
Effective Date 2025-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
clotrimazole (1 g)
Inactive Ingredients
peppermint oil simmondsia chinensis (jojoba) seed oil phenoxyethanol camphor (synthetic) sodium citrate carbomer aqua glyceryl stearate cetostearyl alcohol pentylene glycol triethanolamine gentiana scabra root caprylic/capric triglyceride glycerin ethylhexylglycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-12-26

Description

Clotrimazole 1%


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Clotrimazole 1%

Indications and Usage

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Dosage and Administration

• Wash the affected area and dry thoroughly.

• Apply a thin layer over affected area twice daily (morning and night), or as directed by a doctor.

• Supervise children in the use of this product.

• For athlete's foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.

• For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.

• If conditions persists longer, consult a doctor.

• This product is not effective on the scalp or nails.

Description

Clotrimazole 1%

Section 50565-1

Keep out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Section 50566-9

If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.

Section 50567-7

Avoid contact with eyes.

Section 50570-1

on children under 2 years of age unless directed by a doctor.

Section 51727-6

Aqua, Cetostearyl Alcohol, Caprylic/Capric Triglyceride, Glycerin, Glyceryl Stearate, Pentylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Phenoxyethanol, Ethylhexylglycerin, Camphor, Carbomer, Peppermint Oil, Gentiana Extract, Triethanolamine, Sodium Citrate

Section 51945-4

Section 53413-1

Contact us at [email protected]

Section 55105-1

Antifungal

Section 60561-8

• Store at controlled room temperature 15°–30°C (59°–86°F).

• Close cap tightly after use.


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Clotrimazole 1%

Indications and Usage (34067-9)

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Dosage and Administration (34068-7)

• Wash the affected area and dry thoroughly.

• Apply a thin layer over affected area twice daily (morning and night), or as directed by a doctor.

• Supervise children in the use of this product.

• For athlete's foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.

• For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.

• If conditions persists longer, consult a doctor.

• This product is not effective on the scalp or nails.

Section 50565-1 (50565-1)

Keep out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.

Section 50567-7 (50567-7)

Avoid contact with eyes.

Section 50570-1 (50570-1)

on children under 2 years of age unless directed by a doctor.

Section 51727-6 (51727-6)

Aqua, Cetostearyl Alcohol, Caprylic/Capric Triglyceride, Glycerin, Glyceryl Stearate, Pentylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Phenoxyethanol, Ethylhexylglycerin, Camphor, Carbomer, Peppermint Oil, Gentiana Extract, Triethanolamine, Sodium Citrate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Contact us at [email protected]

Section 55105-1 (55105-1)

Antifungal

Section 60561-8 (60561-8)

• Store at controlled room temperature 15°–30°C (59°–86°F).

• Close cap tightly after use.


Advanced Ingredient Data


Raw Label Data

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