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Tolnaftate

Premier Brands of America Inc.

Antifungal Powder Spray




FULL PRESCRIBING INFORMATION

Tolnaftate 1%

Antifungal

  • cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)

  • can prevent recurrence of most athlete's foot
  • relieves symptoms of athlete's foot, including itching, burning, cracking and chafing associated with jock itch

For external use only.

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF.

  • do not get into eyes or mouth
  • use only as directed

Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

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

If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer 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
  • use daily for 4 weeks for athletes foot, ringworm and for jock itch use daily for 2 weeks
  • if conditions persist, consult a doctor
  • to prevent athlete's foot, apply daily once or twice daily (morning and/or night)
  • this product is not effective on the scalps or nails
  • in case of clogging, clear nozzle under running water

store between 20º and 30ºC (68ºF and 86º)

BHT, isobutane (propellent), PPG-12-buteth-16, SD alcohol 40-B (14%w/w), talc

Call 1-866-964-0939

Premier

Medicated
Antifungal
Powder Spray
Tolnaftate 1%

  • Cures and prevents most athletes foot
  • Relieves itching and burning

NET WT 4.6 FL OZ (130g)

Tolnaftate

Tolnaftate

Antifungal Powder Spray AEROSOL, POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:56104-002
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Tolnaftate TOLNAFTATE 1.3 g

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
isobutane
PPG-12-buteth-16
ALCOHOL
talc

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:56104-002-46 130 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2013-01-01


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