85992-002 Oniadba Fungal Nail Treatment Swabs

Drug Facts

Composition & Product

Active Ingredients

Tolnaftate (1 g) Undecylenic Acid (25 g)

Inactive Ingredients

C12-15 Alkyl Lactate Alcohol Water Edetate Disodium Ethylhexylglycerin Phenoxyethanol Dimethicone Tocopherol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-08-06

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

Wash the affected area and dry thoroughly.

Snap off the tip swabbelow red line. Liquid will begin flowing into the other end of swab tip.

The swab applicator allows for easy application to the skin around the nail.

Apply a thin layer of liquid over the affected area twice daily(morning and night) or as directed by a doctor.

Supervise children inthe use of product.

Pay attention to the spaces between the toeswear well-fitingventilated shoes, and change shoes and socks at least once dailye

Allow the nail and surrounding areas to dry.

Use only oneswab per treatment.

Please continue to use this product for at least 4 weeks.

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 ifyou experience any signs ofsensitivity or irritation

Section 51727-6

ALCOHOL,DIMETHICONE, C12-15 ALKYLLACTATE.ETHYLHEXYLGLYCERIN.TOCOPHEROL,EDETATE DISODIUM.PHENOXYETHANOL，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)

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)

Wash the affected area and dry thoroughly.

Snap off the tip swabbelow red line. Liquid will begin flowing into the other end of swab tip.

The swab applicator allows for easy application to the skin around the nail.

Apply a thin layer of liquid over the affected area twice daily(morning and night) or as directed by a doctor.

Supervise children inthe use of product.

Pay attention to the spaces between the toeswear well-fitingventilated shoes, and change shoes and socks at least once dailye

Allow the nail and surrounding areas to dry.

Use only oneswab per treatment.

Please continue to use this product for at least 4 weeks.

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 ifyou experience any signs ofsensitivity or irritation

Section 51727-6 (51727-6)

ALCOHOL,DIMETHICONE, C12-15 ALKYLLACTATE.ETHYLHEXYLGLYCERIN.TOCOPHEROL,EDETATE DISODIUM.PHENOXYETHANOL，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

[{"name": "C12-15 ALKYL LACTATE", "unii": "GC844VRD7E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOLNAFTATE", "unii": "06KB629TKV", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "UNDECYLENIC ACID", "unii": "K3D86KJ24N", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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.", "34068-7": "Wash the affected area and dry thoroughly. Snap off the tip swabbelow red line. Liquid will begin flowing into the other end of swab tip. The swab applicator allows for easy application to the skin around the nail. Apply a thin layer of liquid over the affected area twice daily(morning and night) or as directed by a doctor. Supervise children inthe use of product. Pay attention to the spaces between the toeswear well-fitingventilated shoes, and change shoes and socks at least once dailye Allow the nail and surrounding areas to dry. Use only oneswab per treatment. Please continue to use this product for at least 4 weeks.", "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", "50565-1": "If accidental ingestion occurs, seek medical assistance or contact a Poison Control Center immediately", "50566-9": "If the area of application shows increased irritation If there is no improvement within 8 weeks If pregnant or breastfeeding", "50567-7": "Not for use in the eyes, mouth, or vaginal area", "50570-1": "Do not use ifyou experience any signs ofsensitivity or irritation", "51727-6": "ALCOHOL,DIMETHICONE, C12-15 ALKYLLACTATE.ETHYLHEXYLGLYCERIN.TOCOPHEROL,EDETATE DISODIUM.PHENOXYETHANOL，WATER", "55105-1": "Anti-fungal", "55106-9": "Tolnaftate 1% Undecylenic Acid 25%"}