Thera Plus Antifungal Clotrimazole Cream
FDA Label NDC 80684-039

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fourstar Group Usa, Inc. for the product Thera Plus Antifungal Clotrimazole (NDC 80684-039). 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, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Clotrimazole 1% w/w

Purpose

Antifungal

Uses

  • cures most athlete’s foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which can accompany these conditions.

Warnings

For external use only.

Do Not Use

  • on children under 2 years of age except under the advice of a doctor.

When Using This Product

  • avoid contact with eyes.

Stop Use And Ask A Doctor If

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

If Pregnant Or Breast-Feeding,

ask a health professional before use

Keep This And All Drugs Out Of The Reach Of Children.

if swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • wash the affected area and dry thoroughly.
  • apply a thin layer over affected area twice daily (morning and night)
  • 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 room temperature 20°-25°C (68°-77°F).
  • close cap tightly after use.

Inactive Ingredients

cetostearyl alcohol, ethylparaben, glycerin, glyceryl monostearate, mineral oil, peregal O-25, petrolatum, purified water, stearic acid

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