Pedikleer Cream
FDA Label NDC 57237-354

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Pedikleer (NDC 57237-354). 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 drug factsactive ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of itching, burning, and cracking.

Warnings

For external use only.

Do not use on children under 2 years of age except under the advice and supervision of 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

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
  • use daily for 4 weeks; if condition persists longer, ask a doctor. 
  • to prevent athlete's foot, apply once or twice daily (morning and/or night) 
  • this product is not effective on the scalp or nails

Other Information

  • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
  • store between 20° to 25°C (68° to 77°F)
  • Lot No. & Expiration Date: see box or crimp of tube

Inactive Ingredients

Cetostearyl alcohol, chlorocresol, light mineral oil, monobasic sodium phosphate, polyoxyl 20 cetyl ether, propylene glycol, water, white petrolatum.

Questions Or Comments?

Call 1-844-474-7464

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