Tinactin
FDA Label NDC 11523-0072

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 11523-0072). 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, otc - do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • cures most jock itch
  • for effective relief of itching, chafing and burning

Otc - Do Not Use

For external use only

Flammable: Do not use while smoking or near heat or flame

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

When Using This Product

  • avoid contact with the eyes
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement within 2 weeks

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
  • shake can well and spray 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
  • in case of clogging, clean nozzle with a pin

Other Information

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

Inactive Ingredients

alcohol denat. (11% v/v), butylated hydroxytoluene, isobutane, PPG-12-buteth-16, talc

Questions?

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