Pedikleer

Pedikleer
SPL v1
SPL
SPL Set ID 83396c51-7107-4d98-9d80-ebf6584f4dc8
Route
TOPICAL
Published
Effective Date 2025-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Cetostearyl Alcohol Chlorocresol Light Mineral Oil Sodium Phosphate, Monobasic Polyoxyl 20 Cetostearyl Ether Propylene Glycol Water White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-16

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of itching, burning, and cracking.
Section 50565-1

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

Section 51945-4

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: G/25/1362

Issued: 12/2025

Warnings

For external use only.

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

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks
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
  • 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 scalp or nails
Drug Facts

Tolnaftate 1%

Other Information 
  • TAMPER EVIDENT:  DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
  • store between 20º to 25ºC (68º to 77ºF)
  • Lot No. & Expiration Date: see box or crimp of tube
Inactive Ingredients

Cetostearyl alcohol, chlorocresol, light mineral oil, monobasic sodium phosphate, polyoxyl 20 cetyl ether, propylene glycol, water, white petrolatum.

Questions Or Comments?

Call 1-844-474-7464


Structured Label Content

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of itching, burning, and cracking.
Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: G/25/1362

Issued: 12/2025

Purpose

Antifungal

Warnings

For external use only.

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

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks
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
  • 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 scalp or nails
Drug Facts

Tolnaftate 1%

Other Information 
  • TAMPER EVIDENT:  DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
  • store between 20º to 25ºC (68º to 77ºF)
  • Lot No. & Expiration Date: see box or crimp of tube
Inactive Ingredients

Cetostearyl alcohol, chlorocresol, light mineral oil, monobasic sodium phosphate, polyoxyl 20 cetyl ether, propylene glycol, water, white petrolatum.

Questions Or Comments? (Questions or comments?)

Call 1-844-474-7464


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)