Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID ee99cd87-549f-4a43-878e-b4d5935de0e0
Route
TOPICAL
Published
Effective Date 2023-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1.5 g)
Inactive Ingredients
Butylated Hydroxytoluene Isobutane Ppg-12-buteth-16 Alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-28

Description

Active ingredient Purpose Tolnaftate 1% Anti-fungal


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Uses ■ proven clinically effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) ■ prevents the recurrence of most athlete's foot with daily use ■ for effective relief of itching, cracking and burning

Dosage and Administration

Directions ■ wash affected area and dry thoroughly ■ shake can well and spray a thin layer over affected area twice daily (morning and night) ■ supervise children in the use of this product ■ for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily ■ use daily for 4 weeks ■ if condition persists, 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.

Description

Active ingredient Purpose Tolnaftate 1% Anti-fungal

Section 44425-7

Other information store between 20º and 30º C (68º-86ºF) 

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if ■ Irritation occurs ■ no improvement within 4 weeks

Section 50567-7

When using this product ■ avoid contact with eyes or mouth ■ use only as directed

Section 50570-1

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

Section 51727-6

Inactive ingredients   BHT, isobutane (propellant), PPG-12-buteth-16, SD alcohol 40-B (36% w/w)

Section 55105-1
Active ingredient Purpose
Tolnaftate 1% Anti-fungal
Principal Display Panel

Maximum Strength



HC MAX™



Tolnaftate Anti-Fungal Spray



FOR

ATHLETE'S

FOOT



Clinically Proven To

Cure AND

Prevent

Most Athlete's Foot



Cools

On Contact




Triple Action

Formula Relieves




✓ Itching  

✓ Burning 

✓ Cracking



NET WT 5.3 OZ (150 g)



KRAMER

LABORATORIES



Distributed by:

Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894

          

K0521


Structured Label Content

Indications and Usage (34067-9)

Uses ■ proven clinically effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) ■ prevents the recurrence of most athlete's foot with daily use ■ for effective relief of itching, cracking and burning

Dosage and Administration (34068-7)

Directions ■ wash affected area and dry thoroughly ■ shake can well and spray a thin layer over affected area twice daily (morning and night) ■ supervise children in the use of this product ■ for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily ■ use daily for 4 weeks ■ if condition persists, 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.

Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

Other information store between 20º and 30º C (68º-86ºF) 

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if ■ Irritation occurs ■ no improvement within 4 weeks

Section 50567-7 (50567-7)

When using this product ■ avoid contact with eyes or mouth ■ use only as directed

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   BHT, isobutane (propellant), PPG-12-buteth-16, SD alcohol 40-B (36% w/w)

Section 55105-1 (55105-1)
Active ingredient Purpose
Tolnaftate 1% Anti-fungal
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Maximum Strength



HC MAX™



Tolnaftate Anti-Fungal Spray



FOR

ATHLETE'S

FOOT



Clinically Proven To

Cure AND

Prevent

Most Athlete's Foot



Cools

On Contact




Triple Action

Formula Relieves




✓ Itching  

✓ Burning 

✓ Cracking



NET WT 5.3 OZ (150 g)



KRAMER

LABORATORIES



Distributed by:

Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894

          

K0521


Advanced Ingredient Data


Raw Label Data

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