Clotrimazole
FDA Label NDC 61360-2002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Taro Pharmaceuticals, Inc. for the product Clotrimazole (NDC 61360-2002). 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 other, active ingredient, purpose, uses, warnings, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • for effective relief of
  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
  • discomfort

Warnings

For external use only

Otc - Ask Doctor

Ask a doctor before use

  • on children under 2 years of age

Otc - When Using

When using this product

  • avoid contact with eyes

Otc - Stop Use

Stop use and ask a doctor if

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

Otc - Keep Out Of Reach Of Children

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

Directions

This product is not effective on the scalp or nails.

For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

  • clean the affected area and dry thoroughly
  • apply a thin layer of the 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 spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily

Other Information

  • To open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 2°- 30°C (36° - 86°F)
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions?

Call 1-866-923-4914

Principal Display Panel - 15 G Carton

Cures Most Athlete's Foot

Athlete's Foot
Cream
Clotrimazole Cream USP,1%
Antifungal Cream

Antifungal Cream

NET WT (1/2 oz) 15 g

Principal Display Panel (15 g Carton)

Principal Display Panel (15 g Carton)

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