Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID e901c834-dcac-4d12-85f2-655ca9239cfe
Route
TOPICAL
Published
Effective Date 2011-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (.56 g)
Inactive Ingredients
Carbomer Copolymer Type A Propylene Glycol Xanthan Gum Water Arginine Hydrochloride Sodium Chloride Aloe Vera Leaf Allantoin Althaea Officinalis Root Echinacea Angustifolia Leaf Ascophyllum Nodosum Tagetes Erecta Flower Stearyl Alcohol Methylisothiazolinone Menthol Eucalyptus Globulus Leaf Glyceryl Monostearate Olive Oil Polyoxyl 40 Hydrogenated Castor Oil Azadirachta Indica Seed Oil Isopropyl Alcohol Melaleuca Alternifolia Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-07-27
Description

Tolnaftate 1%

Purpose

Antifungal

Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Uses
■  Proven clinically effective in the treatment of athlete's foot.

■  Relieves itching and burning feet.

Labeling






Warnings
■  Do not use on children under 2 years of age.

■  Do not use for diaper rash.

■  For external use only.

■  Avoid contact with eyes.

Reference

Distributed by BioChemics dba Bio-Scriptives

99 Rosewood Dr. #260 - Danvers, MA 01923

978-750-0790



Directions
■  Wash the feet and dry thoroughly.

■  Apply a thin layer of product to the feet once or twice daily (morning and/or night).

■  Supervise children in the use of this product.

■  Pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.

■  Do not use if safety seal is broken.



Active Ingredients

Tolnaftate 1%

Inactive Ingredients

Purified Water, Glyceryl Stearate SE, Stearyl Alcohol, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Olive Oil, Menthol, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, L-Arginine hydroxide, PEG-40 Hdrogenated Castor Oil, Eucalyptus Globulus, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Althaea Officinalis Extract, Echinacea Angustifolia Extract, Allantoin, Tagetes Erecta Extract, Sodium Chloride, Ascophyllum Nodosum Extract, Xanthan Gum, Azadirachta Indica (Neem) Seed Oil, Methylisothiazolinone

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

Keep Out of Reach of Children

Enter section text here

Structured Label Content

Uses
■  Proven clinically effective in the treatment of athlete's foot.

■  Relieves itching and burning feet.

Purpose

Antifungal

Labeling






Warnings
■  Do not use on children under 2 years of age.

■  Do not use for diaper rash.

■  For external use only.

■  Avoid contact with eyes.

Reference

Distributed by BioChemics dba Bio-Scriptives

99 Rosewood Dr. #260 - Danvers, MA 01923

978-750-0790



Directions
■  Wash the feet and dry thoroughly.

■  Apply a thin layer of product to the feet once or twice daily (morning and/or night).

■  Supervise children in the use of this product.

■  Pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.

■  Do not use if safety seal is broken.



Active Ingredients

Tolnaftate 1%

Inactive Ingredients

Purified Water, Glyceryl Stearate SE, Stearyl Alcohol, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Olive Oil, Menthol, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, L-Arginine hydroxide, PEG-40 Hdrogenated Castor Oil, Eucalyptus Globulus, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Althaea Officinalis Extract, Echinacea Angustifolia Extract, Allantoin, Tagetes Erecta Extract, Sodium Chloride, Ascophyllum Nodosum Extract, Xanthan Gum, Azadirachta Indica (Neem) Seed Oil, Methylisothiazolinone

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

Keep Out of Reach of Children (Keep out of reach of children)

Enter section text here

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:18.003576 · Updated: 2026-03-14T22:52:43.918749