Clearderm Anti Fungal Cream
FDA Label NDC 55629-030

13 label sections · Submitted to the FDA by One2zee Limited Liability Company · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by One2zee Limited Liability Company for the product Clearderm Anti Fungal Cream (NDC 55629-030). 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

Miconazole Nitrate 2% w/w

Purpose

Antifungal

Uses

For the treatment and prevention of most:

  • Athlete's foot
  • Jock itch
  • Ringworm
  • Relieves itching, scaling, cracking, and discomfort associated with these conditions

Warnings

  • For external use only

Do Not Use

on children under 2 years of age unless directed by 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 2 weeks (for jock itch)

Keep Out Of Reach Of Children.

In case of accidental ingestion contact a physician or Poison Control Center right away and discomfort which accompany these conditions

Directions

  • Cleanse affected area and dry thoroughly.
  • Apply a thin layer to affected area twice daily or as directed by a physician
  • Supervise children in the use of this product
  • For athlete's foot and ringworm use daily for 4 weeks; for jock itch use daily for 2 weeks
  • For athlete's foot pay special attention to space between the toes; wear well-fitting
  • Ventilated shoes and change shoes and socks at least once daily. This product is not effective on the scalp or nails

Other Information

  • Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

Caprylic/Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Chlorocresol, Dimethicone, Disodium EDTA, Glyceryl Stearate, Imidazolidinyl Urea, PEG-100 Stearate, PEG-40 Castor Oil, Petrolatum, Propylene Glycol, Sodium Cetearyl Sulfate, Stearic Acid, Water, Xanthan Gum

Questions And Comments?

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