Derman Antifungal Cream

Derman Antifungal Cream
SPL v4
SPL
SPL Set ID 15d9b3c9-01af-4083-a1bc-014505d8798d
Route
TOPICAL
Published
Effective Date 2022-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Ceteth-20 Cetyl Alcohol Chlorocresol Mineral Oil Sodium Phosphate, Monobasic, Unspecified Form Petrolatum Propylene Glycol Water Stearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-07-01 Until 2027-10-28

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Uses
  • cures most athlete's foot, jock itch, and ringworm 
  • relieves itching, burning, cracking, scaling, redness, soreness, irritation and discomfort
Warnings

Directions
  • 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 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
Do Not Use

on children under 2 years of age unless directed by a doctor.

For external use only.

Avoid contact with eyes.

Drug Facts

Active Ingredient

Tolnaftate 1%

Other Information

store at 15 to 30°C (59° to 86°F)

DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING. Tamper Evident:

Inactive Ingredients

ceteth-20, cetyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, petrolatum, propylene glycol, purified water, stearyl alcohol

Package Labeling:25g

Package Labeling:50g

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Stop Use and Ask A Doctor If 
  • irritation occurs
  • there is no improvement within 4 weeks for athlete's foot and ringworm or 2 weeks for jock itch

Structured Label Content

Uses
  • cures most athlete's foot, jock itch, and ringworm 
  • relieves itching, burning, cracking, scaling, redness, soreness, irritation and discomfort
Purpose

Antifungal

Warnings

Directions
  • 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 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
Do Not Use (Do not use)

on children under 2 years of age unless directed by a doctor.

For external use only.

Avoid contact with eyes.

Drug Facts

Active Ingredient (Active ingredient)

Tolnaftate 1%

Other Information (Other information)

store at 15 to 30°C (59° to 86°F)

DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING. Tamper Evident:

Inactive Ingredients (Inactive ingredients)

ceteth-20, cetyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, petrolatum, propylene glycol, purified water, stearyl alcohol

Package Labeling:25g

Package Labeling:50g

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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: 800-222-1222.

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

Advanced Ingredient Data


Raw Label Data

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