SPL v1
SPL
SPL Set ID 0a000d77-7de9-6078-e063-6394a90a8a01
Route
TOPICAL
Published
Effective Date 2023-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Water Glycerin Garlic Allantoin Tea Tree Oil Lonicera Japonica Flower Angelica Sinensis Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-12

Description

Tolnaftate 1%

Purpose

Anti-fungal


Medication Information

Purpose

Anti-fungal

Description

Tolnaftate 1%

Use

for relief and treatment of pain,

soreness, and inflammation from nail

fungus. Symptoms:

■discolored nails

■brittle nails

■distorted nails

Warnings

For external use only. Some individuals may be sensitive to essential oils. Begin with a small drop to determine if product causes any irritation. Discontinue use if any irritation occurs. Stop use and consult a doctor if condition worsens. Not for use on children under the age of 2 without physician direction.

Ask Doctor

ask doctor in case of Sensitive Skin

Directions

shake well before use.

Wash and thoroughly dry the affected

area. Apply 1-2 drops and gently rub

into affected area three times per day.

Wash hands after applying.

Do Not Use

If you feel uncomfortable, please stop using it

When Using

Use after cleansing skin

Active Ingredient

Tolnaftate 1%

Other Information

*Keep in cool dark place

*Store upright

*Tighten cap after use to prevent

oxidation

Inactive Ingredients

Water,Lonicerae Japonicae flos,Angelicae,Glycerin, Allantoin, Garlic Extract, Tea Tree Oil.

Principal Display Panel

Keep Oot of Reach of Children

If pregnant or breast-feeding, ask a

health professional before use. If

accidental ingestion and adverse

reaction occurs, get medical help or

contact a Poison Control Center.


Structured Label Content

Use

for relief and treatment of pain,

soreness, and inflammation from nail

fungus. Symptoms:

■discolored nails

■brittle nails

■distorted nails

Purpose

Anti-fungal

Warnings

For external use only. Some individuals may be sensitive to essential oils. Begin with a small drop to determine if product causes any irritation. Discontinue use if any irritation occurs. Stop use and consult a doctor if condition worsens. Not for use on children under the age of 2 without physician direction.

Ask Doctor

ask doctor in case of Sensitive Skin

Directions

shake well before use.

Wash and thoroughly dry the affected

area. Apply 1-2 drops and gently rub

into affected area three times per day.

Wash hands after applying.

Do Not Use (Do not use)

If you feel uncomfortable, please stop using it

When Using

Use after cleansing skin

Active Ingredient

Tolnaftate 1%

Other Information (Other information)

*Keep in cool dark place

*Store upright

*Tighten cap after use to prevent

oxidation

Inactive Ingredients (Inactive ingredients)

Water,Lonicerae Japonicae flos,Angelicae,Glycerin, Allantoin, Garlic Extract, Tea Tree Oil.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

If pregnant or breast-feeding, ask a

health professional before use. If

accidental ingestion and adverse

reaction occurs, get medical help or

contact a Poison Control Center.


Advanced Ingredient Data


Raw Label Data

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