84614-002 Toenail Fungus Treatment Maximum Strength Liquid

84614-002 Toenail Fungus Treatment Maximum Strength Liquid
SPL v2
SPL
SPL Set ID 1fb03184-5f21-c82a-e063-6294a90a9fa4
Route
TOPICAL
Published
Effective Date 2024-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Undecylenic Acid Alcohol Water Tocopherol Phenoxyethanol Edetate Disodium Dimethicone C12-15 Alkyl Lactate Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-23

Description

TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH Liquid


Medication Information

Warnings and Precautions

Keep away from fire and flame.

Keep out of reach of children.

For use on nails and the immediately adjacent skin only.

Indications and Usage

Antifungal use on fingemails, toenails, and the immediately adjacent skin.

Fungal nails, Athlete's Foot, Tinea Manuum, Ringwomcaused byfungus and bacterial infection.

For all caused by nail fungus, nail discoloration, nail thickening,nailsplitting, nail crumbling

Dosage and Administration

Use once daily, preferably before bedtimeUnscrew the cap and tilt the bottle to apply the medicine directly to thenail. The medication will then penetrate deeply into the nail.If the nail area is infected, spray the medication onto the affected toearea.

Description

TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH Liquid

Section 42229-5

TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH Liquid

Section 44425-7

SHAKE WELL BEFORE USE

Store at room temperature 5--30°C(41°-86°F), Please store in a cool,dry place away from direct sunlight.

Keep tightly closed when not in use

Section 50565-1

If accidental ingestion occurs, seek medical assistance or contact a Poison Control Center immediately.

Section 50566-9

lf the area of application shows signs of increased iritation.

There is no improvement within 8 weeks.

When Pregnant or breast-feeding

Section 50567-7

Not for ophthalmic, oral, or intravaginal use

Section 50570-1

If a reaction suggesting sensitivity or iritation occurs.

Section 51727-6

UNDECYLENIC ACID

ALCOHOL

DIMETHICONE

C12-15 ALKYL LACTATE

ETHYLHEXYLGLYCERIN

TOCOPHEROL

EDETATE DISODIUM

PHENOXYETHANOL

WATER

Section 51945-4

Section 55105-1

Anti-fungal and Nail Renewal

Section 55106-9

Tolnaftate 1%


Structured Label Content

Indications and Usage (34067-9)

Antifungal use on fingemails, toenails, and the immediately adjacent skin.

Fungal nails, Athlete's Foot, Tinea Manuum, Ringwomcaused byfungus and bacterial infection.

For all caused by nail fungus, nail discoloration, nail thickening,nailsplitting, nail crumbling

Dosage and Administration (34068-7)

Use once daily, preferably before bedtimeUnscrew the cap and tilt the bottle to apply the medicine directly to thenail. The medication will then penetrate deeply into the nail.If the nail area is infected, spray the medication onto the affected toearea.

Warnings and Precautions (34071-1)

Keep away from fire and flame.

Keep out of reach of children.

For use on nails and the immediately adjacent skin only.

Section 42229-5 (42229-5)

TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH Liquid

Section 44425-7 (44425-7)

SHAKE WELL BEFORE USE

Store at room temperature 5--30°C(41°-86°F), Please store in a cool,dry place away from direct sunlight.

Keep tightly closed when not in use

Section 50565-1 (50565-1)

If accidental ingestion occurs, seek medical assistance or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

lf the area of application shows signs of increased iritation.

There is no improvement within 8 weeks.

When Pregnant or breast-feeding

Section 50567-7 (50567-7)

Not for ophthalmic, oral, or intravaginal use

Section 50570-1 (50570-1)

If a reaction suggesting sensitivity or iritation occurs.

Section 51727-6 (51727-6)

UNDECYLENIC ACID

ALCOHOL

DIMETHICONE

C12-15 ALKYL LACTATE

ETHYLHEXYLGLYCERIN

TOCOPHEROL

EDETATE DISODIUM

PHENOXYETHANOL

WATER

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-fungal and Nail Renewal

Section 55106-9 (55106-9)

Tolnaftate 1%


Advanced Ingredient Data


Raw Label Data

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