Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID bc8a5492-8bd0-4c80-a270-e4958aeb5ed6
Route
TOPICAL
Published
Effective Date 2023-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Aloe Vera Leaf Ascorbic Acid Dimethicone Dmdm Hydantoin Edetate Disodium Eucalyptol Glycerin Glyceryl Stearate Se Lavender Oil Mineral Oil Olive Oil Peg-100 Stearate Phenoxyethanol Propylene Glycol Tea Tree Oil Titanium Dioxide .alpha.-tocopherol Acetate Xanthan Gum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-01-20 Until 2027-01-01

Description

Active ingredient Purpose Tolnaftate 1% Anti-fungal


Medication Information

Description

Active ingredient Purpose Tolnaftate 1% Anti-fungal

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.

Section 50570-1

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

Section 55106-9
Active ingredient Purpose
Tolnaftate 1% Anti-fungal
Warnings

For external use only.

Directions:
  • Clean affected area with soap and warm water and dry thoroughly. 
  • Apply a thin layer of Maximum Strength Antifungal over affected area twice daily (morning and night) or as directed by a doctor.

  • The brush applicator allows for easy application to skin around the nail.
  • 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.

  • For toe fungus, apply to skin around nails. If condition persists longer, consult a doctor.

  • This product is not effective on the scalp or nails.

  • Supervise children in the use of this product.

Package Label

THE ONLY PRODUCT THAT

1. Improves Nail Appearance AND

2. Kills Fungus Around the Nail



NEW



Opti-Nail™

2-in-1




FUNGAL NAIL REPAIR + ANTI-FUNGAL



1

Improves Nail Appearance

Fungal Nail Repair Formula



Apply directly on nail



Visible Results Starting in Just 2 DAYS



Net Wt 5mL

(.169 fl oz)



2

Kills Fungus Around Nail

Maximum Strength Antifungal (1% Tolnaftate)



Apply to skin around nail



Clinically Proven to

Cure & Prevent

Fungal Infections*



Net Wt 5mL 

(.169 fl oz)



INCLUDES:

1% Tolnaftate Antifungal Solution AND Fungal Nail Repair Formula 



*restores skin health + cures most athlete's foot



Step 1



Apply Fungal Nail Repair Formula

Directly On Nail



Clinically Proven Formula that results In Healthier Looking Nails

✓  Visible Results Starting in Just 2 Days

✓  Triple Action Formula Lightens, Smooths, and Moisturizes

✓  Easy to Apply & Dries Quickly



Apply twice a day for 4 weeks, then use once daily as needed. 



Fungal Nail Repair Formula Ingredients:

Ethyl lactate, glycerin, water, lactic acid, resacetophenone, citric acid (if needed for pH balance). 



For External Use only. Apply only to nail surface.

Avoid contact with eyes and mucus membranes.

Do not use if you are allergic to any of the ingredients in this product.

Keep out of reach of children.

Diabetics should ask a doctor before use. 

Sunburn Alert: may increase your skin's sensitivity to the sun and particularly the possibility of sunburn.



See package insert for full Opti-Nail 2-1 product instructions 



Do not use if neck band is missing or broken



K0322



Fungal Nail Repair Formula does not treat, cure, or prevent fungal infections. 



© 2022 Kramer Laboratories, Inc. Bridgewater, NJ 08807

Questions or Comments? Call 1-800-824-4894



Patent pending 



Step 2



Apply Maximum Strength Antifungal 

On Skin Around Nail



Clinically Proven to

Cure & Prevent

Fungal Infections



✓  Kills Fungus

✓  Stops Itching and Burning

✓  Restores Skin Health + Cures Most Athletes Foot



Maximum Strength Anti-Fungal not for nail or scalp fungus. Cures most athlete's foot. 

Opti-Nail™ 2-in-1 Fungal Nail Repair + Antifungal



Directions For Use

Always apply step 1 BEFORE Step 2

First clean affected areas with soap and water and dry thoroughly




Step 1



Apply Fungal Nail Repair Formula

(Green side) to Nail Surface




Unscrew the green cap.



Using the applicator, apply a thin layer of solution directly on entire affected nail surface twice daily (morning and evening).



(Solution looks clear.)



Nail surface will appear wet after application. Avoid applying to skin around the nail.



After applying, recap tightly and allow treated nails(s) to dry for a few minutes before beginning Step 2.



Apply twice a day for 4 weeks, then use once daily as needed to maintain look.



For external use only. Avoid contact with skin. Apply only to nail surface. Avoid contact with eyes and mucous membranes. In case of contact with eyes, rinse cautiously with water for several minutes. May cause irritation if applied to skin. Discontinue use in the event of an allergic reaction or irritation. Do not use if you are allergic to any of the ingredients in the product. Keep out of reach of children. Avoid inhalation. Diabetics should ask doctor before use.

Sunburn Alert: This product contains alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use sunscreen, wear protective clothing, and limit sun exposure while using this product for a week afterwards. Product is flammable, do not use near an open flame.



Fungal Nail Repair Formula Ingredients: Ethyl lactate, glycerin, water, lactic acid, resacetophenone, citric acid (if needed for pH balance).

Fungal Nail Repair Formula does not treat, cure, or prevent fungal infections



Step 2



Apply Maximum Strength Antifungal

(Blue side) to Skin Around Nail



Unscrew the blue cap.



Using the applicator, apply a thin layer of medicine to skin around nails twice daily (morning and evening).



(Medicine looks white to off-white.)



After applying, recap tightly and allow treated area to dry for a few minutes before putting on socks and shoes.



Apply twice a day for 4 weeks.



For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs of it there is no improvement within 4 weeks. Keep out of reach of children. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.



Maximum Strength Antifungal: Active ingredient: Tolnaftate 1%   Inactive ingredients: aloe vera (aloe barbadensis) gel, ascorbic acid (vitamin C), dimethicone, DMDM hydantoin, edetate disodium dihydrate, eucalyptol, glycerin, glyceryl stearate SE, lavender oil, mineral oil, olive oil, PEG-100 stearate, phenoxetol, propylene glycol, tea tree oil, titanium dioxide, tocopheryl acetate (vitamin E), xanthan gum, water



Maximum Strength Antifungal is not effective for nail or scalp fungus. Cures most athlete's foot.



©2022 Kramer Laboratories, Inc. Bridgewater, NJ 08807

Questions or Comments? Call 1-800-824-4894

Patent pending



Store at room temperature 15°−30°C (59°−86°F)



K0322

Other Information

Store at room temperature 15º−30ºC (59º−86ºF).

Inactive Ingredients

aloe vera (aloe barbadensis) gel, ascorbic acid (vitamin C), dimethicone, DMDM hydantoin, edetate disodium dihydrate, eucalyptol, glycerin, glyceryl stearate SE, lavender oil, mineral oil, olive oil, PEG-100 stearate, phenoxetol, propylene glycol, tea tree oil, titanium dioxide, alpha tocopheryl acetate (vitamin E), xanthan gum, water

When Using This Product
  • avoid contact with eyes.
Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks.
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.


Structured Label Content

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.

Section 50570-1 (50570-1)

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

Section 55106-9 (55106-9)
Active ingredient Purpose
Tolnaftate 1% Anti-fungal
Warnings

For external use only.

Directions:
  • Clean affected area with soap and warm water and dry thoroughly. 
  • Apply a thin layer of Maximum Strength Antifungal over affected area twice daily (morning and night) or as directed by a doctor.

  • The brush applicator allows for easy application to skin around the nail.
  • 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.

  • For toe fungus, apply to skin around nails. If condition persists longer, consult a doctor.

  • This product is not effective on the scalp or nails.

  • Supervise children in the use of this product.

Package Label (PACKAGE LABEL)

THE ONLY PRODUCT THAT

1. Improves Nail Appearance AND

2. Kills Fungus Around the Nail



NEW



Opti-Nail™

2-in-1




FUNGAL NAIL REPAIR + ANTI-FUNGAL



1

Improves Nail Appearance

Fungal Nail Repair Formula



Apply directly on nail



Visible Results Starting in Just 2 DAYS



Net Wt 5mL

(.169 fl oz)



2

Kills Fungus Around Nail

Maximum Strength Antifungal (1% Tolnaftate)



Apply to skin around nail



Clinically Proven to

Cure & Prevent

Fungal Infections*



Net Wt 5mL 

(.169 fl oz)



INCLUDES:

1% Tolnaftate Antifungal Solution AND Fungal Nail Repair Formula 



*restores skin health + cures most athlete's foot



Step 1



Apply Fungal Nail Repair Formula

Directly On Nail



Clinically Proven Formula that results In Healthier Looking Nails

✓  Visible Results Starting in Just 2 Days

✓  Triple Action Formula Lightens, Smooths, and Moisturizes

✓  Easy to Apply & Dries Quickly



Apply twice a day for 4 weeks, then use once daily as needed. 



Fungal Nail Repair Formula Ingredients:

Ethyl lactate, glycerin, water, lactic acid, resacetophenone, citric acid (if needed for pH balance). 



For External Use only. Apply only to nail surface.

Avoid contact with eyes and mucus membranes.

Do not use if you are allergic to any of the ingredients in this product.

Keep out of reach of children.

Diabetics should ask a doctor before use. 

Sunburn Alert: may increase your skin's sensitivity to the sun and particularly the possibility of sunburn.



See package insert for full Opti-Nail 2-1 product instructions 



Do not use if neck band is missing or broken



K0322



Fungal Nail Repair Formula does not treat, cure, or prevent fungal infections. 



© 2022 Kramer Laboratories, Inc. Bridgewater, NJ 08807

Questions or Comments? Call 1-800-824-4894



Patent pending 



Step 2



Apply Maximum Strength Antifungal 

On Skin Around Nail



Clinically Proven to

Cure & Prevent

Fungal Infections



✓  Kills Fungus

✓  Stops Itching and Burning

✓  Restores Skin Health + Cures Most Athletes Foot



Maximum Strength Anti-Fungal not for nail or scalp fungus. Cures most athlete's foot. 

Opti-Nail™ 2-in-1 Fungal Nail Repair + Antifungal



Directions For Use

Always apply step 1 BEFORE Step 2

First clean affected areas with soap and water and dry thoroughly




Step 1



Apply Fungal Nail Repair Formula

(Green side) to Nail Surface




Unscrew the green cap.



Using the applicator, apply a thin layer of solution directly on entire affected nail surface twice daily (morning and evening).



(Solution looks clear.)



Nail surface will appear wet after application. Avoid applying to skin around the nail.



After applying, recap tightly and allow treated nails(s) to dry for a few minutes before beginning Step 2.



Apply twice a day for 4 weeks, then use once daily as needed to maintain look.



For external use only. Avoid contact with skin. Apply only to nail surface. Avoid contact with eyes and mucous membranes. In case of contact with eyes, rinse cautiously with water for several minutes. May cause irritation if applied to skin. Discontinue use in the event of an allergic reaction or irritation. Do not use if you are allergic to any of the ingredients in the product. Keep out of reach of children. Avoid inhalation. Diabetics should ask doctor before use.

Sunburn Alert: This product contains alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use sunscreen, wear protective clothing, and limit sun exposure while using this product for a week afterwards. Product is flammable, do not use near an open flame.



Fungal Nail Repair Formula Ingredients: Ethyl lactate, glycerin, water, lactic acid, resacetophenone, citric acid (if needed for pH balance).

Fungal Nail Repair Formula does not treat, cure, or prevent fungal infections



Step 2



Apply Maximum Strength Antifungal

(Blue side) to Skin Around Nail



Unscrew the blue cap.



Using the applicator, apply a thin layer of medicine to skin around nails twice daily (morning and evening).



(Medicine looks white to off-white.)



After applying, recap tightly and allow treated area to dry for a few minutes before putting on socks and shoes.



Apply twice a day for 4 weeks.



For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs of it there is no improvement within 4 weeks. Keep out of reach of children. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.



Maximum Strength Antifungal: Active ingredient: Tolnaftate 1%   Inactive ingredients: aloe vera (aloe barbadensis) gel, ascorbic acid (vitamin C), dimethicone, DMDM hydantoin, edetate disodium dihydrate, eucalyptol, glycerin, glyceryl stearate SE, lavender oil, mineral oil, olive oil, PEG-100 stearate, phenoxetol, propylene glycol, tea tree oil, titanium dioxide, tocopheryl acetate (vitamin E), xanthan gum, water



Maximum Strength Antifungal is not effective for nail or scalp fungus. Cures most athlete's foot.



©2022 Kramer Laboratories, Inc. Bridgewater, NJ 08807

Questions or Comments? Call 1-800-824-4894

Patent pending



Store at room temperature 15°−30°C (59°−86°F)



K0322

Other Information (Other information)

Store at room temperature 15º−30ºC (59º−86ºF).

Inactive Ingredients (Inactive ingredients)

aloe vera (aloe barbadensis) gel, ascorbic acid (vitamin C), dimethicone, DMDM hydantoin, edetate disodium dihydrate, eucalyptol, glycerin, glyceryl stearate SE, lavender oil, mineral oil, olive oil, PEG-100 stearate, phenoxetol, propylene glycol, tea tree oil, titanium dioxide, alpha tocopheryl acetate (vitamin E), xanthan gum, water

When Using This Product (When using this product)
  • avoid contact with eyes.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks.
Keep This and All Medication Out of the Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)