Clotrimazole Cream
FDA Label NDC 73581-451

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Yyba Corp for the product Clotrimazole (NDC 73581-451). 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, keep out of reach of children, uses, warnings, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Keep Out Of Reach Of Children

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

Uses

  • Cures most athlete's foot, jock itch and ringworm.
  • Relieves itching, burning, cracking, scaling, and discomfort

Warnings

For external use only.

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

When using this productavoid contact with eyes

Stop use and ask doctor if

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

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer 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 atlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Inactive Ingredients

Ceteareth 20, Cetostearyl Alcohol, Methylparaben, Mineral Oil, Propylene Glycol, Propylparaben, Purified Water, White Petrolatum

* Please review the disclaimer below.