Drug Facts

Drug Facts
SPL v14
SPL
SPL Set ID cabf84c1-1500-46fe-b226-b16d4a0666c7
Route
TOPICAL
Published
Effective Date 2024-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Propylene Glycol Mineral Oil Stearyl Alcohol Cetyl Alcohol Sorbitan Monostearate Ceteth-20 Water Methylparaben Propylparaben

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-06-01

Description

Tolnaftate 1%


Medication Information

Warnings and Precautions

For external use only

When using this productavoid contact with the eyes

Stop use and ask a doctor if

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

Do not useon children under 2 years of age unless directed by a doctor

Indications and Usage
  • Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • For effective relief of itching, burning and cracking
Dosage and Administration
  •  Wash affected area and dry thoroughly
  • Apply 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 shows 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 longer consult a doctor
  • This product is not effective on scalp or nails
Description

Tolnaftate 1%

Section 50565-1

Keep out of reach of children.  If Swallowed, get medical help or contact a Poison Control center right away.

Section 51727-6

Ceteth 20, Cetyl Alcohol, Methylparaben, Mineral Oil, Propylene Glycol, Propylparaben, Sorbitan Monostearate, Steryl Alcohol, Purified Water 

Section 51945-4

Section 55105-1

Antifungal

Section 55106-9

Tolnaftate 1%


Structured Label Content

Indications and Usage (34067-9)
  • Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • For effective relief of itching, burning and cracking
Dosage and Administration (34068-7)
  •  Wash affected area and dry thoroughly
  • Apply 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 shows 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 longer consult a doctor
  • This product is not effective on scalp or nails
Warnings and Precautions (34071-1)

For external use only

When using this productavoid contact with the eyes

Stop use and ask a doctor if

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

Do not useon children under 2 years of age unless directed by a doctor

Section 50565-1 (50565-1)

Keep out of reach of children.  If Swallowed, get medical help or contact a Poison Control center right away.

Section 51727-6 (51727-6)

Ceteth 20, Cetyl Alcohol, Methylparaben, Mineral Oil, Propylene Glycol, Propylparaben, Sorbitan Monostearate, Steryl Alcohol, Purified Water 

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Tolnaftate 1%


Advanced Ingredient Data


Raw Label Data

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