Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID e21ccb83-54ff-4605-80bf-7b4b789c7cb7
Route
TOPICAL
Published
Effective Date 2021-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Aloe Vera Leaf Carbomer Homopolymer Type A (allyl Pentaerythritol Crosslinked) Dimethicone 350 Eucalyptol Lavender Oil Glyceryl Monostearate Olive Oil Phenoxyethanol Poloxamer 188 Water Sodium Hydroxide Tea Tree Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-15

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

■ Clean affected areas with soap and warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail® Anti-Fungal Ointment 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 under nail and around cuticle area. 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.

Description

Active Ingredient Purpose Tolnaftate 1% Anti-fungal

Section 44425-7

Other information

Store at controlled room temperature 15º-30º C ( 59º-86º F) Protect from freezing. If freezing occurs warm to room temperature.

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 Vera Leaf, Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked), Dimethicone 350, Eucalyptol, Lavender Oil, Glyceryl Monostearate, Olive Oil, Phenoxyethanol, Poloxamer 188, Purified Water USP, Sodium Hydroxide, Tea Tree Oil

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

OINTMENT




with brush applicator



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



NET WT 0.7 OZ (20 g)



Convenient and Easy to Apply



Deep Penetrating Medicine that Stays in Place



Not actual size.

Patent pending.



Maximum Strength

Anti-Fungal

PLUS

5 natural oils:



○ aloe vera

○ tea tree

○ eucalyptol

○ lavender

○ olive oil



For best results treat around all toenails and in between toes.



Not for Nail or scalp fungus.



Cures most athlete's foot.



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



K1120


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)

■ Clean affected areas with soap and warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail® Anti-Fungal Ointment 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 under nail and around cuticle area. 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.

Section 44425-7 (44425-7)

Other information

Store at controlled room temperature 15º-30º C ( 59º-86º F) Protect from freezing. If freezing occurs warm to room temperature.

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 Vera Leaf, Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked), Dimethicone 350, Eucalyptol, Lavender Oil, Glyceryl Monostearate, Olive Oil, Phenoxyethanol, Poloxamer 188, Purified Water USP, Sodium Hydroxide, Tea Tree Oil

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

OINTMENT




with brush applicator



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



NET WT 0.7 OZ (20 g)



Convenient and Easy to Apply



Deep Penetrating Medicine that Stays in Place



Not actual size.

Patent pending.



Maximum Strength

Anti-Fungal

PLUS

5 natural oils:



○ aloe vera

○ tea tree

○ eucalyptol

○ lavender

○ olive oil



For best results treat around all toenails and in between toes.



Not for Nail or scalp fungus.



Cures most athlete's foot.



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



K1120


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)