Alcohol- Free

Alcohol- Free
SPL v4
SPL
SPL Set ID adf30db8-8e0a-6f9d-e053-2a95a90a5890
Route
TOPICAL
Published
Effective Date 2019-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Dioxolane Disodium Lauroamphodiacetate Sodium Laurate Cottonseed Oil Peppermint Oil .alpha.-tocopherol Acetate Ammonium Acryloyldimethyltaurate/vp Copolymer Ethylhexyl Stearate Edetate Disodium Anhydrous Eucalyptus Oil Dilauryl Citrate Phenoxyethanol Caprylyl Glycol Sodium Lauroyl Sarcosinate Water Propanediol

Identifiers & Packaging

Pill Appearance
Shape: rectangle Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-11

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Uses

• proven clinically effective in the treatment of most athlete's foot 9tinea pedis) and ringworm (tinea corporis)

• helps prevent most athlete's foot with daily use

• for effective relief of itching, burning and cracking

Label

SMOOTH

AF TM

Relief reinvented

Alcohol-free

athlete's foot

cure and

prevention

Advanced anti-fungal medication

NOW WITHOUT THE NEED FOR CREAMS OR SPRAYS

Open up and say ahhhh

30 Treatment Towels

7.0in x 7.75in (17.8cm x 19.6cm)

PODIATRIST RECOMMENDED

SMOOTHAF

A spa day in a towel

A better way to prevent

and cure athlete's foot,

while making feet feel

clean, refreshed and

SMOOTHAF.

The Clean Cure

Podiatrist recommended

anti-fungal medication.

paraben-free, cures and

prevents athlete's foot.

Safe and effective.

Distributed by:

Pelli Skin Co., LLC.

Mission, Texas

getsmoothaf.com

SMOOTHAF

Wipes on clean.

Smells fresh.

Gentle enough to use daily.

Goes anywhere you do.

•PATENT

PENDING

•APPROVED

AMERICAN PODIATRIC

MEDICAL

ASSOCIATION

•PROUDLY

MADE IN THE

USA

•PARABEN

FREE

•RAINFOREST ALLIANCE

CERTIFIED

•MIX Paper

FSC FSC R C109834

Warnings

For external use only

Questions
Directions

• wash affected area with soap and water and dry thoroughly

• unfold and use towel to thoroughly clean and massage solution into entire foot soles, around and between toes

• sue new towel daily for 4 weeks; if condition persists longer, ask a doctor

• dispose of uses towel in bin, do not flush

• to prevent athlete's foot, use towel as directed once or twice daily (morning and/or night)

• for athlete's foot, wear well fitting, ventilated shoes and change shoes and socks at least once daily

• this product is not effective on the scalp or nails

Do Not Use

Do not use on children under 2 years of age except under advice and supervision of a doctor.

Active Ingredient

Tolnaftate 1%

Other Information

Store between 20°–25°C (68°–77°F)

Inactive Ingredients

Water, Propanediol, Dioxolane, Mentha Piperita (Peppermint) Oil, Eucalyptus Globulus Leaf Oil, Gossypium Herbaceum (Cotton) Seed Oil, Sodium Lauroyl Sarcosinate, Sodium Lauroamphoacetate, Ethylhexyl Stearate, Sorbitan Laurate, Polyglyceryl-4 Laurate, Dilauryl Citrate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol

When Using This Product

When using this product avoid contact with the eyes.

• use only as directed; intentional misuse by deliberately concentrating and inhaling may harmful or fatal

Stop Use and Ask A Doctor

• if irritation occurs • there is no improvement within 4 weeks

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

• proven clinically effective in the treatment of most athlete's foot 9tinea pedis) and ringworm (tinea corporis)

• helps prevent most athlete's foot with daily use

• for effective relief of itching, burning and cracking

Label

SMOOTH

AF TM

Relief reinvented

Alcohol-free

athlete's foot

cure and

prevention

Advanced anti-fungal medication

NOW WITHOUT THE NEED FOR CREAMS OR SPRAYS

Open up and say ahhhh

30 Treatment Towels

7.0in x 7.75in (17.8cm x 19.6cm)

PODIATRIST RECOMMENDED

SMOOTHAF

A spa day in a towel

A better way to prevent

and cure athlete's foot,

while making feet feel

clean, refreshed and

SMOOTHAF.

The Clean Cure

Podiatrist recommended

anti-fungal medication.

paraben-free, cures and

prevents athlete's foot.

Safe and effective.

Distributed by:

Pelli Skin Co., LLC.

Mission, Texas

getsmoothaf.com

SMOOTHAF

Wipes on clean.

Smells fresh.

Gentle enough to use daily.

Goes anywhere you do.

•PATENT

PENDING

•APPROVED

AMERICAN PODIATRIC

MEDICAL

ASSOCIATION

•PROUDLY

MADE IN THE

USA

•PARABEN

FREE

•RAINFOREST ALLIANCE

CERTIFIED

•MIX Paper

FSC FSC R C109834

Purpose

Antifungal

Warnings

For external use only

Questions
Directions

• wash affected area with soap and water and dry thoroughly

• unfold and use towel to thoroughly clean and massage solution into entire foot soles, around and between toes

• sue new towel daily for 4 weeks; if condition persists longer, ask a doctor

• dispose of uses towel in bin, do not flush

• to prevent athlete's foot, use towel as directed once or twice daily (morning and/or night)

• for athlete's foot, wear well fitting, ventilated shoes and change shoes and socks at least once daily

• this product is not effective on the scalp or nails

Do Not Use (Do not use)

Do not use on children under 2 years of age except under advice and supervision of a doctor.

Active Ingredient

Tolnaftate 1%

Other Information (Other information)

Store between 20°–25°C (68°–77°F)

Inactive Ingredients (Inactive ingredients)

Water, Propanediol, Dioxolane, Mentha Piperita (Peppermint) Oil, Eucalyptus Globulus Leaf Oil, Gossypium Herbaceum (Cotton) Seed Oil, Sodium Lauroyl Sarcosinate, Sodium Lauroamphoacetate, Ethylhexyl Stearate, Sorbitan Laurate, Polyglyceryl-4 Laurate, Dilauryl Citrate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol

When Using This Product (When using this product)

When using this product avoid contact with the eyes.

• use only as directed; intentional misuse by deliberately concentrating and inhaling may harmful or fatal

Stop Use and Ask A Doctor (Stop use and ask a doctor)

• if irritation occurs • there is no improvement within 4 weeks

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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