Dermatin Cream
FDA Label NDC 54473-096

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Dermatin (NDC 54473-096). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients
Clotrimazole 1%

Otc - Purpose

Purpose
Antifungal

Indications & Usage

Uses

  • Cures most athlete's foot, jock itch, and ringworm
  • Relieves itching, burning, cracking, scaling, and discomfort accompanying these conditions

Warnings

Warnings
For external use only

  • When using this product avoid contact with the eyes

Otc - Do Not Use

Do not use on children under 2 years of age unless directed by a doctor

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 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.

Dosage & Administration

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a physician
  • children under 12 years of age should be supervised 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
  • for athletes foot and ringworm, use daily for 4 weeks: for jock itch, use daily for 2 weeks
  • this product is not effective on scalp or nails

Inactive Ingredient

Other ingredients  Water, T36 C5 Melaleuca Oil, Stearic Acid, Cetyl alcohol, SD Alcohol 40B, Glyceryl Stearate and PEG 100 Stearate, Steareth 21, Propylene Glycol, Dimethicone, Acrylates/C10-30 Alkylacrylates Crosspolymer, Triethanolamine, Steareth 2, Benzyl Alcohol, Methylsothiazolinone, BHT.

* Please review the disclaimer below.