Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID a3ae043b-dc97-449b-b099-70bdf8e92482
Route
TOPICAL
Published
Effective Date 2025-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Aloe Vera Leaf Benzoic Acid Caprylyl Glycol Carbomer Homopolymer Type A (allyl Pentaerythritol Crosslinked) Cinnamomum Massoy Bark Oil Citric Acid Monohydrate Cocos Nucifera Whole Dimethicone 350 Ethylhexylglycerin Eucalyptol Eugenia Uniflora Leaf Glycerin Glyceryl Monostearate Lavender Oil Tea Tree Oil Olive Oil Phenoxyethanol Poloxamer 188 Sodium Carbonate Sodium Hydroxide Thyme Triethyl Citrate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-25

Description

Active Ingredient Purpose 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 areas with soap and warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail® Anti-Fungal Liquid 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. If condition persists longer, consult 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. ■ Supervise children in the use of this product.

Description

Active Ingredient Purpose 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 aloe barbadensis leaf juice, benzoic acid, caprylyl glycol, carbomer, cinnamomum zeylanicum bark oil, citric acid, cocos nucifera (coconut) oil, dimethicone, ethylhexylglycerin, eucalyptol, eugenia caryophyllus (clove) leaf oil, glycerin, glyceryl stearate, lavandula hybrida grosso herb oil, melaleuca alternifolia (tea tree) leaf oil, olea europaea (olive) fruit oil, phenoxyethanol, poloxamer 188, sodium carbonate, sodium hydroxide, thymus vulgaris (thyme) oil, triethyl citrate, water.

Section 55105-1
Active Ingredient Purpose
Tolnaftate 1% Anti-fungal
Section 55106-9



Warnings

For external use only.

Principal Display Panel

MAXIMUM

STRENGTH




FUNGI-NAIL®

ANTI-FUNGAL

LIQUID




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



1 FL. OZ. (30mL)



NEW FORMULA



FUNGI-NAIL®

Maximum Strength

Anti-Fungal plus

9 natural oils:

○ aloe vera

○ tea tree

○ coconut

○ lavender

○ olive oil

○ thyme

○ cloves

○ cinnamon

○ eucalyptol



Deep Penetrating Medicine

that Stays in Place

Convenient & Easy to Apply



For more information about

Fungi-Nail® and money back

guarantee, visit us at funginail.com



Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894



K0825



Not actual size.



For best results treat skin around all

toenails and in between toes. Not for nail

or scalp fungus. Cures most athlete's foot.



Do not use if safety seal

is missing or broken

MAXIMUM

STRENGTH




FUNGI-NAIL®

ANTI-FUNGAL

SPRAY



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



1 FL. OZ. (30mL)



NEW FORMULA



FUNGI-NAIL®

Maximum Strength

Anti-Fungal plus

9 natural oils:

○ aloe vera

○ tea tree

○ coconut

○ lavender

○ olive oil

○ thyme

○ cloves

○ cinnamon

○ eucalyptol



Deep Penetrating Medicine

that Stays in Place

Convenient & Easy to Apply



For more information about

Fungi-Nail® and money back

guarantee, visit us at funginail.com



Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894



K0825



Not actual size.



For best results treat skin around all

toenails and in between toes. Not for nail

or scalp fungus. Cures most athlete's foot.



Do not use if safety seal is missing or broken

MAXIMUM STRENGTH



FUNGI-NAIL®

ANTI-FUNGAL

SPRAY




CLINICALLY PROVEN TO

CURE AND PREVENT

FUNGAL INFECTIONS



1 FL OZ (30mL)



Distributed by:

KRAMER

LABORITORIES

K0622



Kramer Laboratories, Inc. Bridgewater, NJ 08807

kramerlabs.com funginal.com 1-800-824-4894



MAXIMUM

STRENGTH




FUNGI

-NAIL®


ANTI-FUNGAL

LIQUID




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



0.5 FL. OZ. (15mL)



NEW FORMULA



FUNGI-NAIL®

Maximum Strength

Anti-Fungal plus

9 natural oils:

○ aloe vera

○ tea tree

○ coconut

○ lavender

○ olive oil

○ thyme

○ cloves

○ cinnamon

○ eucalyptol



Deep Penetrating Medicine

that Stays in Place

Convenient & Easy to Apply



For more information about

Fungi-Nail® and money back

guarantee, visit us at funginail.com



Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894



K0825



Not actual size.



For best results treat skin around all

toenails and in between toes. Not for nail

or scalp fungus. Cures most athlete's foot.



Do not use if safety seal

is missing or broken


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 areas with soap and warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail® Anti-Fungal Liquid 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. If condition persists longer, consult 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. ■ 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 aloe barbadensis leaf juice, benzoic acid, caprylyl glycol, carbomer, cinnamomum zeylanicum bark oil, citric acid, cocos nucifera (coconut) oil, dimethicone, ethylhexylglycerin, eucalyptol, eugenia caryophyllus (clove) leaf oil, glycerin, glyceryl stearate, lavandula hybrida grosso herb oil, melaleuca alternifolia (tea tree) leaf oil, olea europaea (olive) fruit oil, phenoxyethanol, poloxamer 188, sodium carbonate, sodium hydroxide, thymus vulgaris (thyme) oil, triethyl citrate, water.

Section 55105-1 (55105-1)
Active Ingredient Purpose
Tolnaftate 1% Anti-fungal
Section 55106-9 (55106-9)



Warnings

For external use only.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

MAXIMUM

STRENGTH




FUNGI-NAIL®

ANTI-FUNGAL

LIQUID




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



1 FL. OZ. (30mL)



NEW FORMULA



FUNGI-NAIL®

Maximum Strength

Anti-Fungal plus

9 natural oils:

○ aloe vera

○ tea tree

○ coconut

○ lavender

○ olive oil

○ thyme

○ cloves

○ cinnamon

○ eucalyptol



Deep Penetrating Medicine

that Stays in Place

Convenient & Easy to Apply



For more information about

Fungi-Nail® and money back

guarantee, visit us at funginail.com



Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894



K0825



Not actual size.



For best results treat skin around all

toenails and in between toes. Not for nail

or scalp fungus. Cures most athlete's foot.



Do not use if safety seal

is missing or broken

MAXIMUM

STRENGTH




FUNGI-NAIL®

ANTI-FUNGAL

SPRAY



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



1 FL. OZ. (30mL)



NEW FORMULA



FUNGI-NAIL®

Maximum Strength

Anti-Fungal plus

9 natural oils:

○ aloe vera

○ tea tree

○ coconut

○ lavender

○ olive oil

○ thyme

○ cloves

○ cinnamon

○ eucalyptol



Deep Penetrating Medicine

that Stays in Place

Convenient & Easy to Apply



For more information about

Fungi-Nail® and money back

guarantee, visit us at funginail.com



Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894



K0825



Not actual size.



For best results treat skin around all

toenails and in between toes. Not for nail

or scalp fungus. Cures most athlete's foot.



Do not use if safety seal is missing or broken

MAXIMUM STRENGTH



FUNGI-NAIL®

ANTI-FUNGAL

SPRAY




CLINICALLY PROVEN TO

CURE AND PREVENT

FUNGAL INFECTIONS



1 FL OZ (30mL)



Distributed by:

KRAMER

LABORITORIES

K0622



Kramer Laboratories, Inc. Bridgewater, NJ 08807

kramerlabs.com funginal.com 1-800-824-4894



MAXIMUM

STRENGTH




FUNGI

-NAIL®


ANTI-FUNGAL

LIQUID




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



0.5 FL. OZ. (15mL)



NEW FORMULA



FUNGI-NAIL®

Maximum Strength

Anti-Fungal plus

9 natural oils:

○ aloe vera

○ tea tree

○ coconut

○ lavender

○ olive oil

○ thyme

○ cloves

○ cinnamon

○ eucalyptol



Deep Penetrating Medicine

that Stays in Place

Convenient & Easy to Apply



For more information about

Fungi-Nail® and money back

guarantee, visit us at funginail.com



Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894



K0825



Not actual size.



For best results treat skin around all

toenails and in between toes. Not for nail

or scalp fungus. Cures most athlete's foot.



Do not use if safety seal

is missing or broken


Advanced Ingredient Data


Raw Label Data

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