Clotrimazole Cream
FDA Label NDC 68788-8830

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Preferred Pharmaceuticals Inc. for the product Clotrimazole (NDC 68788-8830). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - keep out of reach of children, do not use, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Clotrimazole USP 1% w/w

Purpose

Antifungal Cream

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.

Warnings

For External use only.

Otc - Keep Out Of Reach Of Children

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.

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, Laureth-23, Mineral Oil, Petrolatum, Water, alcohol, Glyceryl mono and dipalmitostearate, Cetostearyl alcohol, edetate disodium, Butylated Hydroxytoluene.

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: Preferred Pharmaceuticals Inc.

NDC 68788-8330-2

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