85992-004 Oniadba Nail Fungus Treatment Pen

85992-004 Oniadba Nail Fungus Treatment Pen
SPL v1
SPL
SPL Set ID 3bad19f1-d5b3-c5de-e063-6294a90a0c03
Route
TOPICAL
Published
Effective Date 2025-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g) Undecylenic Acid (25 g)
Inactive Ingredients
Laurocapram Chlorhexidine Diacetate Alcohol Caramel Water Sorbitol Propylene Glycol Angelica Dahurica Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-06

Description

Tolnaftate 1% Undecylenic Acid 25%


Medication Information

Warnings and Precautions



Keep away from fire and flames.

Keep out of reach of children.

For external use on nails and the immediately adjacent skin only.

Indications and Usage

Antifungal treatment for fingernails, toenails, and surrounding skin.Effective against fungal nails.athlete's foot, tinea manuum, and ringworm caused by fungi.Addresses nail fungus,discoloration, thickening, splitting, and crumbling

Dosage and Administration

Water, Sorbitol, Alcohol, Propylene Glycol,Angelica Dahurica,Chlorhexidine Diacetate Hydrate, Laurocapram, Caramel

Description

Tolnaftate 1% Undecylenic Acid 25%

Section 50565-1



If accidental ingestion occurs, seek medical

assistance or contact a Poison Control

Center immediately.

Section 50566-9



If the area of application shows increased irritation

If there is no improvement within 8 weeks.

If pregnant or breastfeeding.

Section 50567-7

Not for use in the eyes, mouth, or vaginal area

Section 50570-1

Do not use if you experience any signsof sensitivity or irritation.

Section 51727-6

Water, Sorbitol, Alcohol, Propylene Glycol,Angelica Dahurica,Chlorhexidine Diacetate Hydrate, Laurocapram, Caramel

Section 51945-4

Section 55105-1

Anti-fungal

Section 55106-9

Tolnaftate 1%

Undecylenic Acid 25%


Structured Label Content

Indications and Usage (34067-9)

Antifungal treatment for fingernails, toenails, and surrounding skin.Effective against fungal nails.athlete's foot, tinea manuum, and ringworm caused by fungi.Addresses nail fungus,discoloration, thickening, splitting, and crumbling

Dosage and Administration (34068-7)

Water, Sorbitol, Alcohol, Propylene Glycol,Angelica Dahurica,Chlorhexidine Diacetate Hydrate, Laurocapram, Caramel

Warnings and Precautions (34071-1)



Keep away from fire and flames.

Keep out of reach of children.

For external use on nails and the immediately adjacent skin only.

Section 50565-1 (50565-1)



If accidental ingestion occurs, seek medical

assistance or contact a Poison Control

Center immediately.

Section 50566-9 (50566-9)



If the area of application shows increased irritation

If there is no improvement within 8 weeks.

If pregnant or breastfeeding.

Section 50567-7 (50567-7)

Not for use in the eyes, mouth, or vaginal area

Section 50570-1 (50570-1)

Do not use if you experience any signsof sensitivity or irritation.

Section 51727-6 (51727-6)

Water, Sorbitol, Alcohol, Propylene Glycol,Angelica Dahurica,Chlorhexidine Diacetate Hydrate, Laurocapram, Caramel

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)