Clotrimazole

Clotrimazole
SPL v12
SPL
SPL Set ID c0f58a0d-a304-41f9-bbdf-c2e488230cf0
Route
TOPICAL
Published
Effective Date 2024-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Clotrimazole 1%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

• cures most athlete’s foot, jock itch and ringworm • relieves itching, burning, cracking, scaling and discomfort which 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) • 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 condition persists longer, consult a doctor • this product is not effective on the scalp or nails

Dosage Forms and Strengths

Product: 50090-0562 NDC: 50090-0562-0 28 g in a TUBE / 1 in a CARTON

Description

Clotrimazole 1%

Section 44425-7

• store at 20°-25°C (68°-77°F)

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9

• irritation occurs • there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch)

Section 50567-7

avoid contact with the eyes

Section 50570-1

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

Section 51727-6

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Section 51945-4

Label Image

Section 53413-1

1-800-719-9260

Section 55105-1

Antifungal

Section 55106-9

Clotrimazole 1%


Structured Label Content

Indications and Usage (34067-9)

• 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)

• wash the affected area and dry thoroughly • apply a thin layer over affected area twice daily (morning and night) • 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 condition persists longer, consult a doctor • this product is not effective on the scalp or nails

Dosage Forms and Strengths (34069-5)

Product: 50090-0562 NDC: 50090-0562-0 28 g in a TUBE / 1 in a CARTON

Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)

• store at 20°-25°C (68°-77°F)

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9 (50566-9)

• irritation occurs • there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch)

Section 50567-7 (50567-7)

avoid contact with the eyes

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Section 51945-4 (51945-4)

Label Image

Section 53413-1 (53413-1)

1-800-719-9260

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Clotrimazole 1%


Raw Label Data

All Sections (JSON)