First Aid Antifungal Medicated Cream

First Aid Antifungal Medicated Cream
SPL v1
SPL
SPL Set ID b65f0815-1e41-035b-e053-2a95a90a8eb9
Route
TOPICAL
Published
Effective Date 2017-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Petrolatum Cetyl Alcohol Mineral Oil Methylparaben Polyethylene Glycol, Unspecified Propylene Glycol Propylparaben Water Sorbitan Monostearate Stearyl Alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-01-02

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Uses
  • proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • proven effective in the prevention of athlete's foot with daily use
  • for effective relief of itching, burning and cracking
Section 42229-5

Distributed by:

First Aid Research Corp.

Jupiter, Florida, USA 33478

Made in India

Section 50565-1

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

Section 50567-7

When using this product avoid contact with the eyes

Section 50570-1

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Warnings

For external use only

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes, wear well fitting shoes and change socks at least once daily
  • use daily for 4 weeks, if condition persists longer, ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalps or nails
Active Ingredient

Tolnaftate 1%

Other Information
  • store between 20 to 25°C (68 to 77°F)
  • Lot No & Expiration Date: See box or see crimp
Inactive Ingredients

petrolatum, cetanol, liquid paraffin, methylparaben, polyoxyethylene,  propylene glycol, propylparaben, purified water, sorbitan monstearate, stearyl alchol.

Principal Display Panel

First Aid Antifungal Medicated Cream

NET WT  1 OZ (28 g)

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks

Structured Label Content

Uses
  • proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • proven effective in the prevention of athlete's foot with daily use
  • for effective relief of itching, burning and cracking
Section 42229-5 (42229-5)

Distributed by:

First Aid Research Corp.

Jupiter, Florida, USA 33478

Made in India

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 50567-7 (50567-7)

When using this product avoid contact with the eyes

Section 50570-1 (50570-1)

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Purpose

Antifungal

Warnings

For external use only

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes, wear well fitting shoes and change socks at least once daily
  • use daily for 4 weeks, if condition persists longer, ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalps or nails
Active Ingredient (Active ingredient)

Tolnaftate 1%

Other Information (Other information)
  • store between 20 to 25°C (68 to 77°F)
  • Lot No & Expiration Date: See box or see crimp
Inactive Ingredients (Inactive ingredients)

petrolatum, cetanol, liquid paraffin, methylparaben, polyoxyethylene,  propylene glycol, propylparaben, purified water, sorbitan monstearate, stearyl alchol.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

First Aid Antifungal Medicated Cream

NET WT  1 OZ (28 g)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)