Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 1a0a3b14-d8f2-4363-b3c9-f5028e8eada3
Route
TOPICAL
Published
Effective Date 2025-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
3-o-ethyl Ascorbic Acid Aloe Vera Leaf Cinnamomum Massoy Bark Oil Citric Acid Monohydrate Cocos Nucifera Whole Dimethicone 350 Edetate Disodium Dmdm Hydantoin Eucalyptol Eugenia Uniflora Leaf Glycerin Glyceryl Stearate Se Lavender Oil Tea Tree Oil Mineral Oil Olive Oil Glyceryl Stearate/peg-100 Stearate Phenoxyethanol Potassium Sorbate Propylene Glycol Docusate Sodium/sodium Benzoate Thyme Titanium Dioxide .alpha.-tocopherol Acetate Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-01

Description

Active Ingredient Purpos e Tolnaftate 1% Anti-fungal


Medication Information

Indications and Usage

Uses  

■ proven 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.

Dosage and Administration

Directions

■ Clean affected area with soap and water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail® Anti-Fungal over affected area twice daily (morning and night) or as directed by a doctor. ■ Wear well-fitting, ventilated shoes and change shoes and socks at least once daily. ■ For athlete's foot pay special attention to spaces between the toes. ■ For athlete's foot and ringworm, use daily for 4 weeks. ■ To prevent athlete's foot, apply once or twice daily (morning and/or night). ■ For toe fungus: apply around nail and cuticle area. ■ The product is not effective on the scalp or nails. ■ Supervise children in the use of this product.

Description

Active Ingredient Purpos e Tolnaftate 1% Anti-fungal

Section 44425-7

Other information

Store at room temperature 15°-30°C (59°-86°F). Protect from freezing. If freezing occurs warm to room temperature. ■ Keep carton for full product information.

Section 50565-1

Keep this and all medication out of the reach of children. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.

Section 50566-9

Stop use and ask a doctor if 

■ irritation occurs ■ there is no improvement within 4 weeks.

Section 50567-7

When using this product avoid contact with eyes.

Section 50570-1

Do not use on children under 2 years of age unless directed by a doctor.

Section 51727-6

Inactive ingredients 3-0-ethyl ascorbic acid, aloe barbadensis leaf juice, cinnamomum zeylanicum bark oil, citric acid, cocos nucifera (coconut) oil, dimethicone, disodium EDTA, DMDM hydantoin, eucalyptol, eugenia caryophyllus (clove) leaf oil, glycerin, glyceryl stearate SE, lavandula angustifolia (lavender) oil, melaleuca alternifolia (tea tree) leaf oil, mineral oil, olea europaea (olive) fruit oil, PEG-100 stearate, phenoxyethanol, potassium sorbate, propylene glycol, sodium benzoate, thymus vulgaris (thyme) oil, titanium dioxide, tocopheryl acetate, water, xanthan gum

Section 55105-1
Active Ingredient Purpose
Tolnaftate 1% Anti-fungal
Warnings

For external use only

Questions

1-800-824-4894

Principal Display Panel

Maximum Strength

Medicine



NEW &

IMPROVED PEN!



MAXIMUM

STRENGTH


FUNG

I-NAIL®


ANTI-FUNGAL

PEN




CLINICALLY PROVEN TO

CURE AND PREVENT 

FUNGAL INFECTIONS



TRIPLE ACTION FORMULA

Kills Fungus

Stops Itching & Burning

Restores Skin Health

    + Cures Most Athlete's Foot



CLINICALLY PROVEN

INGREDIENT



PLUS

Aloe & Tea Tree Oil



.101 FL OZ (3ml)



Easy to Apply

Pen Applicator



K0925



NEW FORMULA



FUNGI-NAIL®

Maximum

Strength

Anti-Fungal


plus 9

natural oils:

○ aloe vera

○ tea tree

○ coconut

○ lavender

○ olive oil

○ thyme

○ cloves

○ cinnamon

○ eucalyptol

and antioxidant

Vitamin E



For more information

about Fungi-Nail ® and

money back guarantee,

visit us at funginail.com



For best results treat skin around all toenails and in between toes. Not for nail or scalp fungus, Cures most athlete's foot.

Kramer Laboratories, Inc., Bridgewater, NJ 08807 1-800-824-4894


Structured Label Content

Indications and Usage (34067-9)

Uses  

■ proven 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.

Dosage and Administration (34068-7)

Directions

■ Clean affected area with soap and water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail® Anti-Fungal over affected area twice daily (morning and night) or as directed by a doctor. ■ Wear well-fitting, ventilated shoes and change shoes and socks at least once daily. ■ For athlete's foot pay special attention to spaces between the toes. ■ For athlete's foot and ringworm, use daily for 4 weeks. ■ To prevent athlete's foot, apply once or twice daily (morning and/or night). ■ For toe fungus: apply around nail and cuticle area. ■ The product is not effective on the scalp or nails. ■ Supervise children in the use of this product.

Section 44425-7 (44425-7)

Other information

Store at room temperature 15°-30°C (59°-86°F). Protect from freezing. If freezing occurs warm to room temperature. ■ Keep carton for full product information.

Section 50565-1 (50565-1)

Keep this and all medication out of the reach of children. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.

Section 50566-9 (50566-9)

Stop use and ask a doctor if 

■ irritation occurs ■ there is no improvement within 4 weeks.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

Section 50570-1 (50570-1)

Do not use on children under 2 years of age unless directed by a doctor.

Section 51727-6 (51727-6)

Inactive ingredients 3-0-ethyl ascorbic acid, aloe barbadensis leaf juice, cinnamomum zeylanicum bark oil, citric acid, cocos nucifera (coconut) oil, dimethicone, disodium EDTA, DMDM hydantoin, eucalyptol, eugenia caryophyllus (clove) leaf oil, glycerin, glyceryl stearate SE, lavandula angustifolia (lavender) oil, melaleuca alternifolia (tea tree) leaf oil, mineral oil, olea europaea (olive) fruit oil, PEG-100 stearate, phenoxyethanol, potassium sorbate, propylene glycol, sodium benzoate, thymus vulgaris (thyme) oil, titanium dioxide, tocopheryl acetate, water, xanthan gum

Section 55105-1 (55105-1)
Active Ingredient Purpose
Tolnaftate 1% Anti-fungal
Warnings

For external use only

Questions

1-800-824-4894

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Maximum Strength

Medicine



NEW &

IMPROVED PEN!



MAXIMUM

STRENGTH


FUNG

I-NAIL®


ANTI-FUNGAL

PEN




CLINICALLY PROVEN TO

CURE AND PREVENT 

FUNGAL INFECTIONS



TRIPLE ACTION FORMULA

Kills Fungus

Stops Itching & Burning

Restores Skin Health

    + Cures Most Athlete's Foot



CLINICALLY PROVEN

INGREDIENT



PLUS

Aloe & Tea Tree Oil



.101 FL OZ (3ml)



Easy to Apply

Pen Applicator



K0925



NEW FORMULA



FUNGI-NAIL®

Maximum

Strength

Anti-Fungal


plus 9

natural oils:

○ aloe vera

○ tea tree

○ coconut

○ lavender

○ olive oil

○ thyme

○ cloves

○ cinnamon

○ eucalyptol

and antioxidant

Vitamin E



For more information

about Fungi-Nail ® and

money back guarantee,

visit us at funginail.com



For best results treat skin around all toenails and in between toes. Not for nail or scalp fungus, Cures most athlete's foot.

Kramer Laboratories, Inc., Bridgewater, NJ 08807 1-800-824-4894


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)