Clotrimazole Cream
FDA Label NDC 63187-559

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Clotrimazole (NDC 63187-559). 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, keep out of reach of children., 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

Uses

  • cures most athlete’s foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which 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 the eyes

Stop Use And Ask A Doctor If

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

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center 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 condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails

Other Information

  • store at 20°-25°C (68°-77°F)

Inactive Ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions Or Comments?

1-800-719-9260

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

Principal Display Panel

Cures Most Athlete’s Foot

Relieves Itching & Burning

Greaseless, Non-Staining

Compare to Lotrimin® AF active ingredient

Clotrimazole Cream USP, 1%

Antifungal

NET WT 1 OZ (30 g)

63187-559-30 (071278e7 550a 4bc0 958c Cfb692c8a9af 01)

63187-559-30 (071278e7 550a 4bc0 958c Cfb692c8a9af 01)

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