Tinactin Cream
FDA Label NDC 11523-0934

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Tinactin (NDC 11523-0934). 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 other, active ingredient, purpose, uses, warnings, otc - when using, stop use and ask a doctor if, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by Bayer Healthcare LLC, Whippany, NJ, USA, 07981.

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • cures most jock itch (tinea cruris)
  • for effective relief of itching, chafing and burning

Warnings

For external use only

Otc - When Using

When using this product avoid contact with the eyes

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement within 2 weeks

Otc - Do Not Use

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

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.

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
  • use daily for 2 weeks; if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other Information

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

ceteth-20, cetostearyl alcohol, chlorocresol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, white petrolatum

Questions?

1-866-360-3266

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