Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 8ed1a08a-3019-4564-968f-154e659c05e1
Route
TOPICAL
Published
Effective Date 2024-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1.3 g)
Inactive Ingredients
Butylated Hydroxytoluene Isobutane Kaolin Ppg-12-buteth-16 Alcohol Zea Mays Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Active Ingredient Purpose Tolnaftate 1% Anti-fungal


Medication Information

Indications and Usage

Use helps prevent most athlete's foot with daily use.

Dosage and Administration

Directions

■ To prevent athlete's foot, wash and dry feet thoroughly

■ Shake can well and spray a thin layer of the product to the feet once or twice daily (morning and/or night)

■ Supervise children in the use of this product.

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

■ In case of clogging, clean nozzle with pin.

Description

Active Ingredient Purpose Tolnaftate 1% Anti-fungal

Section 44425-7

Other information  store between 20° to 25°C (68° to 77°F)

Section 50565-1

KEE OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

When using this product

■ avoid contact with eyes

■ use only as directed.

Stop use and ask a doctor if irritation occurs.

Section 50567-7

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

Section 50570-1

Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmul or fatal.

Section 51727-6

Inactive ingredients  Butylated Hydroxytoluene, Isobutane, Kaolin, PPG-12 Buteth-16, SD Alcohol 40B (14% w/w), Zea Mays (Corn Starch)

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



Warnings

For external use only.

Principal Display Panel

NEW MAXIMUM STRENGTH

FUNGI

NAIL®

TOLNAFTATE ANTI-FUNGAL



EVERYDAY

TOE & FOOT ANTI-FUNGAL

POWDER SPRAY



STOPS

FOOT FUNGUS

BEFORE IT

CAN SPREAD



Use Daily To Prevent

Most Athlete's Foot



▪ Absorbs Wetness

     To Fight Odor

▪ Talc-free



NET WT 4.6 OZ (130 g)



Not for nail or scalp fungus.



For more information about

Fungi-Nail® and money back

guarantee, visit us at funginail.com



Dist. by: Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894



K0524


Structured Label Content

Indications and Usage (34067-9)

Use helps prevent most athlete's foot with daily use.

Dosage and Administration (34068-7)

Directions

■ To prevent athlete's foot, wash and dry feet thoroughly

■ Shake can well and spray a thin layer of the product to the feet once or twice daily (morning and/or night)

■ Supervise children in the use of this product.

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

■ In case of clogging, clean nozzle with pin.

Section 44425-7 (44425-7)

Other information  store between 20° to 25°C (68° to 77°F)

Section 50565-1 (50565-1)

KEE OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

When using this product

■ avoid contact with eyes

■ use only as directed.

Stop use and ask a doctor if irritation occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmul or fatal.

Section 51727-6 (51727-6)

Inactive ingredients  Butylated Hydroxytoluene, Isobutane, Kaolin, PPG-12 Buteth-16, SD Alcohol 40B (14% w/w), Zea Mays (Corn Starch)

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)

NEW MAXIMUM STRENGTH

FUNGI

NAIL®

TOLNAFTATE ANTI-FUNGAL



EVERYDAY

TOE & FOOT ANTI-FUNGAL

POWDER SPRAY



STOPS

FOOT FUNGUS

BEFORE IT

CAN SPREAD



Use Daily To Prevent

Most Athlete's Foot



▪ Absorbs Wetness

     To Fight Odor

▪ Talc-free



NET WT 4.6 OZ (130 g)



Not for nail or scalp fungus.



For more information about

Fungi-Nail® and money back

guarantee, visit us at funginail.com



Dist. by: Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894



K0524


Advanced Ingredient Data


Raw Label Data

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