Antifungal Cream
FDA Label NDC 21922-094

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Encube Ethicals, Inc. for the product Antifungal (NDC 21922-094). 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(s), purpose, use(s), warnings, do not use, when using this product, stop use and ask 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(S)

Clotrimazole, USP 1% 

Purpose

Antifungal

Use(S)

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

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 Doctor If

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

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • wash the affected area and dry thoroughly 
  • apply a thin layer of the product 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
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition lasts longer, contact a doctor
  • this product is not effective on the scalp or nails

Other Information

  • store at room temperature 20°C to 25°C (68°F to 77°F)
  • before using any medication, read all label directions. Keep carton, It contains important information.

Inactive Ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

Questions Or Comments?

Call 1-833-285-4151

Principal Display Panel

Athlete's Foot Cream

Clotrimazole Cream USP, 1% (Antifungal)

NET WT. 0.5 OZ (14 g)

Carton 14 Gm (Carton 14 Gm)

Carton 14 Gm (Carton 14 Gm)

Athlete's Foot Cream

Clotrimazole Cream USP, 1% (Antifungal)

NET WT. 1 OZ (28 g)

Carton 28 Gm (Carton 28 Gm)

Carton 28 Gm (Carton 28 Gm)

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