85578-003 Tegasolve Toenail Fungus Treatment

85578-003 Tegasolve Toenail Fungus Treatment
SPL v1
SPL
SPL Set ID 375b0515-1b1f-23b8-e063-6294a90a9d68
Route
TOPICAL
Published
Effective Date 2025-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (25 g)
Inactive Ingredients
Jojoba Oil Almond Oil Propolis Wax .alpha.-tocopherol Acetate Water Manuka Oil Lavender Oil Clove Oil Oregano Leaf Oil Peppermint Oil Aloe Vera Leaf Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-12
Description

Undecylenic Acid 25%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage



For the effective treatment of most nail fungus, athlete's foot, ringworm, andother skin fungus infections

Helps relieve symptoms such as discoloration, brittleness, thickened orcrumbling nails

Dosage and Administration



1, Clean and dry the affected area thoroughly before application

2, Apply a thin layer of the solution to the affected area twice daily(morningand night)

3, For best results, file affected nails every 2-3 days after soaking in warmwater

4, Continue use for at least 4 weeks, or as directed by a doctor

Description

Undecylenic Acid 25%

Section 50565-1

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

Section 50566-9



Irritation occurs

Condition does not improve within 4 weeks

Section 50567-7



Avoid contact with eyes

If contact occurs, rinse thoroughly with water

Section 50570-1

On children under 2 years of age unless directed by a doctor

Section 51727-6

Aloe Vera Extract

Tea Tree Oil

Clove Bud Oil

Lavender Oil

Jojoba Oil

Manuka Oil

Peppermint Oil

OREGANO LEAF OIL

PROPOLIS

ALMOND OIL

.ALPHA.-TOCOPHEROL ACETATE (Vitamin E)

Purified Water

Section 51945-4

Section 55105-1

Antifungal

Section 55106-9

Undecylenic Acid 25%

Structured Label Content

Indications and Usage (34067-9)



For the effective treatment of most nail fungus, athlete's foot, ringworm, andother skin fungus infections

Helps relieve symptoms such as discoloration, brittleness, thickened orcrumbling nails

Dosage and Administration (34068-7)



1, Clean and dry the affected area thoroughly before application

2, Apply a thin layer of the solution to the affected area twice daily(morningand night)

3, For best results, file affected nails every 2-3 days after soaking in warmwater

4, Continue use for at least 4 weeks, or as directed by a doctor

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)



Irritation occurs

Condition does not improve within 4 weeks

Section 50567-7 (50567-7)



Avoid contact with eyes

If contact occurs, rinse thoroughly with water

Section 50570-1 (50570-1)

On children under 2 years of age unless directed by a doctor

Section 51727-6 (51727-6)

Aloe Vera Extract

Tea Tree Oil

Clove Bud Oil

Lavender Oil

Jojoba Oil

Manuka Oil

Peppermint Oil

OREGANO LEAF OIL

PROPOLIS

ALMOND OIL

.ALPHA.-TOCOPHEROL ACETATE (Vitamin E)

Purified Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Undecylenic Acid 25%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:17.885153 · Updated: 2026-03-14T23:08:59.288880