clotrimazole cream usp, 1%

clotrimazole cream usp, 1%
SPL v3
SPL
SPL Set ID 800a9dab-d287-427e-af6d-26996e0def41
Route
topical
Published
Effective Date 2023-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
clotrimazole (1 g)
Inactive Ingredients
dimethyl sulfoxide ethylparaben glycerin glyceryl stearate se laureth-23 light mineral oil petrolatum stearyl alcohol water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2015-03-10

Purpose

Antifungal Cream

Description

Clotrimazole USP 1% w/w


Medication Information

Warnings

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

● For external use only

● Avoid contact with eyes.

● 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.

Uses

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.

Purpose

Antifungal Cream

Directions
  • Wash the affected area and dry thoroughly.

● Apply a thin layer of this product 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. 

Other Information
  • store at controlled room temperature 15°-30°C (59°- 86°F)
  • Close cap tightly after use.
Inactive Ingredients

Dimethyl Sulfoxide, Ethylparaben, Glycerin, Glyceryl Stearate SE, Laureth-23, Light Mineral Oil, Petrolatum, Stearyl Alcohol, Water

Description

Clotrimazole USP 1% w/w

Questions?

Adverse drug event call 1-888-296-9067

Dist. By Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301, USA

Relabeled By: Proficient Rx LP

Thousand Oaks, CA 91320

Section 50565-1

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

Packaging
Active Ingredient

Clotrimazole USP 1% w/w


Structured Label Content

Warnings

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

● For external use only

● Avoid contact with eyes.

● 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.

Uses

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.

Purpose

Antifungal Cream

Directions
  • Wash the affected area and dry thoroughly.

● Apply a thin layer of this product 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. 

Other Information
  • store at controlled room temperature 15°-30°C (59°- 86°F)
  • Close cap tightly after use.
Inactive Ingredients

Dimethyl Sulfoxide, Ethylparaben, Glycerin, Glyceryl Stearate SE, Laureth-23, Light Mineral Oil, Petrolatum, Stearyl Alcohol, Water

Questions?

Adverse drug event call 1-888-296-9067

Dist. By Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301, USA

Relabeled By: Proficient Rx LP

Thousand Oaks, CA 91320

Section 50565-1 (50565-1)

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

Packaging
Active Ingredient (Active ingredient)

Clotrimazole USP 1% w/w


Advanced Ingredient Data


Raw Label Data

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