83809-015

83809-015
SPL v1
SPL
SPL Set ID 0d78aae8-38f6-432c-e063-6394a90a461b
Route
TOPICAL
Published
Effective Date 2023-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (10 g)
Inactive Ingredients
Water Glycerin Angelica Sinensis Root Garlic Lonicera Japonica Flower Allantoin Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-26

Description

Undecylenic acid 10%

Purpose

Anti-fungal


Medication Information

Purpose

Anti-fungal

Description

Undecylenic acid 10%

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.

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.

Active Ingredient

Undecylenic acid 10%

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.

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.

Active Ingredient

Undecylenic acid 10%

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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