Clotrimazole

Clotrimazole
SPL v1
SPL
SPL Set ID 266d7b94-2954-4831-e063-6394a90a3f33
Route
TOPICAL
Published
Effective Date 2024-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Methylparaben Propylene Glycol White Petrolatum Propylparaben Mineral Oil Water Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-08

Description

Clotrimazole 1% .. Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 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


Medication Information

Warnings and Precautions

For External Use Only

Do not use On children under 2 years of age unless directed by a doctor For diaper rash.

When using this product Avoid contact with the eyes

Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no

improvement within 4 weeks when used for athlete’s foot or ringworm

Indications and Usage

For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)

Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch and itching or burning feet

Description

Clotrimazole 1% .. Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Cetostearyl Alcohol, Methylparaben, Mineral Oil, Macrogol cetostearyl ether, Propylene Glycol, Propylparaben, Purified Water, White Petrolatum

Section 51945-4

Section 55105-1

Antifungal

Warnings

For External Use Only

Do not use On children under 2 years of age unless directed by a doctor For diaper rash.

When using this product Avoid contact with the eyes

Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no

improvement within 4 weeks when used for athlete’s foot or ringworm

Dosage and Admisitration

Clotrimazole 1% ..

Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 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


Structured Label Content

Indications and Usage (34067-9)

For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)

Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch and itching or burning feet

Warnings and Precautions (34071-1)

For External Use Only

Do not use On children under 2 years of age unless directed by a doctor For diaper rash.

When using this product Avoid contact with the eyes

Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no

improvement within 4 weeks when used for athlete’s foot or ringworm

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Cetostearyl Alcohol, Methylparaben, Mineral Oil, Macrogol cetostearyl ether, Propylene Glycol, Propylparaben, Purified Water, White Petrolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Warnings

For External Use Only

Do not use On children under 2 years of age unless directed by a doctor For diaper rash.

When using this product Avoid contact with the eyes

Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no

improvement within 4 weeks when used for athlete’s foot or ringworm

Dosage and Admisitration (DOSAGE AND ADMISITRATION)

Clotrimazole 1% ..

Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 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


Advanced Ingredient Data


Raw Label Data

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