Toenail Fungus Treatment Extra Strength Pen

Toenail Fungus Treatment Extra Strength Pen
SPL v1
SPL
SPL Set ID 28fbcc50-a3ac-d6d1-e063-6294a90aa2b6
Route
TOPICAL
Published
Effective Date 2024-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g) Undecylenic Acid (25 g)
Inactive Ingredients
Tocopherol Safflower Oil Water Propylene Glycol Alcohol Tea Tree Oil Dimethicone Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-11

Description

Toenail Fungus Treatment Extra Strength Pen


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

For the effective treatment of nail fungus,discoloration,thick-ening,splitting,crumbling and brittleness.

Dosage and Administration

Wash and dry your nails before use, Remove the capcovering the brush of the pen.

Twist the end of the pen clockwise to dispense the liquidonto the brush.

Apply the liquid 3 times over the areas that need to berepalred, and make sure to cover all affected parts.

Use 2-3 times daily for 2-4 week s, depending on thecondition of the area that needs repair.

Description

Toenail Fungus Treatment Extra Strength Pen

Section 42229-5

Toenail Fungus Treatment Extra Strength Pen

Section 44425-7

Store between 15° to 30 °C (59 °to 86 °F)Avoid freezing andexcessive heat above 40C°(104F).

Section 50565-1

In case of accidental ingestion, seek medical advice

immediately or contact a Poison Control center right away.

Section 50566-9

lrritation occurs or discomfort persists.

Section 50567-7

Avoid contact with eyes. in case of contact, rinse thoroughly

with water.

Section 50570-1

children under 2 years of age.

pregnant or if there is any allergic reaction to this produce.

Section 51727-6

ALCOHOL

DIMETHICONE

CETOSTEARYL ALCOHOL

TEA TREE OIL

PROPYLENE GLYCOL

TOCOPHEROL

SAFFLOWER OIL

WATER

Section 51945-4

Section 55105-1

Anti-fungal

Section 55106-9

TOLNAFTATE 1%

UNDECYLENIC ACID 25%


Structured Label Content

Indications and Usage (34067-9)

For the effective treatment of nail fungus,discoloration,thick-ening,splitting,crumbling and brittleness.

Dosage and Administration (34068-7)

Wash and dry your nails before use, Remove the capcovering the brush of the pen.

Twist the end of the pen clockwise to dispense the liquidonto the brush.

Apply the liquid 3 times over the areas that need to berepalred, and make sure to cover all affected parts.

Use 2-3 times daily for 2-4 week s, depending on thecondition of the area that needs repair.

Warnings and Precautions (34071-1)

For external use only.

Section 42229-5 (42229-5)

Toenail Fungus Treatment Extra Strength Pen

Section 44425-7 (44425-7)

Store between 15° to 30 °C (59 °to 86 °F)Avoid freezing andexcessive heat above 40C°(104F).

Section 50565-1 (50565-1)

In case of accidental ingestion, seek medical advice

immediately or contact a Poison Control center right away.

Section 50566-9 (50566-9)

lrritation occurs or discomfort persists.

Section 50567-7 (50567-7)

Avoid contact with eyes. in case of contact, rinse thoroughly

with water.

Section 50570-1 (50570-1)

children under 2 years of age.

pregnant or if there is any allergic reaction to this produce.

Section 51727-6 (51727-6)

ALCOHOL

DIMETHICONE

CETOSTEARYL ALCOHOL

TEA TREE OIL

PROPYLENE GLYCOL

TOCOPHEROL

SAFFLOWER OIL

WATER

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-fungal

Section 55106-9 (55106-9)

TOLNAFTATE 1%

UNDECYLENIC ACID 25%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)