Clotrimazole 1% Cream
FDA Label NDC 83324-041

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc. for the product Clotrimazole 1% (NDC 83324-041). 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, otc - keep out of reach of children, uses, warnings, stop use and ask a doctor if:, directions, inactive ingredients, 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

Otc - Keep Out Of Reach Of Children

In case of accidental ingestion, seek professional assistance or contact a Poison Control right away.

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

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

● When using this product avoid contact with eyes.

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.

Inactive Ingredients

Dimethyl Sulfoxide, Ethylparaben, Glycerol, Alcohol, Butylated hydroxytoluene, Cetostearyl alcohol, Edetate disodium, Mineral oil, mono and di glycerides, petrolatum, Polyoxyethylene lauryl ether, purified water.

Other Information

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

Questions Or Comments?

DISTRIBUTED BY: CDMA Inc.

Novi, MI. 48375

www.qualitychoice.com

This product is not manufactured or distributed by Bayer Consumer Care, Inc. owner of the registered trademark Lotrimin® AF

* Please review the disclaimer below.