Elixircurozole Cream
FDA Label NDC 84546-0003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Elixir Healthcare Usa, Llc. for the product Elixircurozole (NDC 84546-0003). 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 ingredients, purposes, indications & usage, warnings, otc - when using, 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

Active Ingredients

Clotrimazole 1% (w/w)

Purposes

Antifungal

Indications & Usage

Uses

  • cures most athlete's foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

Warnings

For external use only

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 or ringworm) or 2 weeks (for jock itch);

Otc - Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Dosage & Administration

Directions

  • wash 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 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, ask a doctor
  • this product is not effective on the scalp or nails

Storage And Handling

Other information

store at 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredients

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Light Mineral Oil, Propylene Glycol, Sodium Metabisulfite, Water.

Principal Display Panel

Elixir

Net Wt. 1 oz. (28.3g)

Compare to the active ingredient in lotrimin AF*

ELIXIR CUROZOLE TM

Antifungal

Relieves Itching, Burning, Cracking & Scaling

*All tradmarks are property of their respective owner. This product is not affiliated with onwer/makers of Lotrimin AF*

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