drug facts

drug facts
SPL v4
SPL
SPL Set ID a09029b2-942e-479d-aa21-453d9a03f60e
Route
topical
Published
Effective Date 2011-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
tolnaftate (1 g)
Inactive Ingredients
cetyl alcohol dodecyl-2-n,n-dimethylaminopropionate hydrochloride methylparaben mineral oil ceteth-10 propylene glycol propylparaben water sorbitan monostearate stearyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2011-08-15

Purpose

Antifungal

Description

Tolnaftate


Medication Information

Warnings

For external use only

Uses
  • Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • Proven effective in the prevention of athlete’s foot
  • Effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet
Purpose

Antifungal

Directions
  • Clean the affected area and dry thoroughly
  • Apply a thin layer over affected area twice a daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete’s foot, pay 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 longer consult a doctor
  • This product is not effective on the scalp or nails
Other Information
  • Store between 20 and 25C (68 to 77F)
  • Lot No. and Exp. Date: see box or see crimp of tube
  • Keep box for complete instructions and labeling
Inactive Ingredients

cetyl  alcohol, dodecyl-2-N N-dimethylaminopropionate hydrochloride, methylparaben, mineral oil, ceteth-10, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

Description

Tolnaftate

Questions?

Call 858-222-8041, Mon-Fri, 8:30 AM - 5:30PM (PST)

Section 51945-4

Do Not Use

on children under 2 years of age except under the advice and supervision of a doctor

Active Ingredient

Tolnaftate

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 (for jock itch) and 4 weeks for (athlete’s foot and ringworm)
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away


Structured Label Content

Warnings

For external use only

Uses
  • Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • Proven effective in the prevention of athlete’s foot
  • Effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet
Purpose

Antifungal

Directions
  • Clean the affected area and dry thoroughly
  • Apply a thin layer over affected area twice a daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete’s foot, pay 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 longer consult a doctor
  • This product is not effective on the scalp or nails
Other Information (Other information)
  • Store between 20 and 25C (68 to 77F)
  • Lot No. and Exp. Date: see box or see crimp of tube
  • Keep box for complete instructions and labeling
Inactive Ingredients

cetyl  alcohol, dodecyl-2-N N-dimethylaminopropionate hydrochloride, methylparaben, mineral oil, ceteth-10, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

Questions?

Call 858-222-8041, Mon-Fri, 8:30 AM - 5:30PM (PST)

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on children under 2 years of age except under the advice and supervision of a doctor

Active Ingredient

Tolnaftate

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Irritation occurs
  • There is no improvement within 2 weeks (for jock itch) and 4 weeks for (athlete’s foot and ringworm)
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


Advanced Ingredient Data


Raw Label Data

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