Fungal Nail Patches — v1

Fungal Nail Patches

3 Views

Version

v1

Effective date

September 28, 2025

Original packager

Yes

Sections captured

12

Identifiers

Document ID
3fe861cc-c973-a328-e063-6294a90afc8f
Set ID
3fe861cc-c972-a328-e063-6294a90afc8f
Application numbers
M005
Product NDCs
85966-006
Package NDCs
85966-006-01
Original packager NDCs
—

Names & Manufacturers

Brand names
Fungal Nail Patches
Generic names
TOLNAFTATE
Manufacturer names
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
TOLNAFTATE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
06KB629TKV
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

TOLNAFTATE 1%
Do Not Use (1)

Sequence 1

Do not use · on children under 2 years of age unless directed by a doctor.
Dosage And Administration (1)

Sequence 1

1.Clean and dry the affected nail and surrounding area. 2.Remove the patch from its protective film. 3.Place it directly onto the infected nail, ensuring full coverage. 4. Gently press down on the edges of the patch to make sure it is firmly adhered to the nail and skin, with no airbubbles. 5. Keep the patch on for 24 hours. Replace it once a day, preferably after showering.
Inactive Ingredient (1)

Sequence 1

WATER UREA LACTIC ACID GLYCERIN TERPINEN-4-OL
Indications And Usage (1)

Sequence 1

For the effective treatment of nall fungus, discoloration, thickening, splitting, crumbling and brittleness. Restore and improve the appearance of nails that have been affected by fungus.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

label
Purpose (1)

Sequence 1

Antifungal
Spl Product Data Elements (1)

Sequence 1

Fungal Nail Patches Tolnaftate GLYCERIN 4-TERPINEOL TOLNAFTATE TOLNAFTATE LACTIC ACID UREA WATER
Stop Use (1)

Sequence 1

Stop use and ask a doctor if . irritation occurs or if there is no improvement within 4 weeks.
Warnings (1)

Sequence 1

For external use only. Store in a cool place and avoid sunshine and heat.
When Using (1)

Sequence 1

When using this product · avoid contact with the eyes or damaged skin.It's normal to feel a slight, temporary sensation of irritation, tingling, or burning. lf symptoms persist or worsen,discontinue use.

OpenFDA raw payload

{'application_number': ['M005'],
 'brand_name': ['Fungal Nail Patches'],
 'generic_name': ['TOLNAFTATE'],
 'is_original_packager': [True],
 'manufacturer_name': ['GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD'],
 'package_ndc': ['85966-006-01'],
 'product_ndc': ['85966-006'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['3fe861cc-c973-a328-e063-6294a90afc8f'],
 'spl_set_id': ['3fe861cc-c972-a328-e063-6294a90afc8f'],
 'substance_name': ['TOLNAFTATE'],
 'unii': ['06KB629TKV']}