Rugby Antifungal Aerosol, Spray
FDA Label NDC 0536-1481

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Rugby Antifungal (NDC 0536-1481). 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, warnings, extremely flammable:, do not use, when using this product, stop use and ask a doctor if, 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 athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
  • helps prevent most athlete's foot with daily use
  • relieves itching, burning, cracking, and chafing associated with jock itch

Warnings

For external use only.

Extremely Flammable:

Keep away from fire, sparks, and heated surfaces. Contents under pressure. Do not puncture or incinerate. Do not store at
temperature above 120°F.

When Using This Product

  • avoid spraying in eyes
  • use only as directed
  • intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal

Stop Use And Ask A Doctor If

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

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 affected area and dry thoroughly
  • shake can well and spray a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • to prevent athlete's foot, shake can well and spray a thin layer of the product to the feet once or twice daily (morning and/or night)
  • 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 persists, consult a doctor
  • this product is not effective on the scalp or nails

Other Information

  • store between 20° and 30°C (68° and 86°F)
  • if nozzle clogs, clean with a pin

Inactive Ingredients

ISOBUTANE, SD ALCOHOL 40-B, KAOLIN, ZEA MAYS (CORN) STARCH, BHT, PPG-12-BUTETH-16

Questions?

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