85966-005 Nail Fungus Treatment Pen

Manufacturer
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | Guangzhou Meixi Biotechnology Co., Ltd.
Effective date
2026-06-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-06-06 05:10:10

Label at a glance#

ProductNail Fungus Treatment Pen
Active ingredientUNDECYLENIC ACID, TOLNAFTATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

UNDECYLENIC ACID 25%
TOLNAFTATE 1%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION


. For the effective treatment of discoloration, thickening, splitting, crumbling and
brittleness.
.Provides effective relief from itching, scaling, burning, redness, soreness, andirritation while curing most athlete's foot (tinea pedis) and jock itch (tinea cruris).
Proven effective in the prevention of most athlete's foot (tinea pedis) with daily use

WARNINGS SECTION

For external use only, Store in a cool place and avoid sunshine and heat.

OTC - DO NOT USE SECTION

Do not use · on children under 2 years of age unless directed by a doctor.

OTC - WHEN USING SECTION

When using this product · avoid contact with the eyes or damaged skin.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION


Clean and dry the affected nail and surrounding area.
Twist the base of the pen clockwise until the brush tip is saturated.
Apply a thin layer to the entire nail. Let it dry for 2-3 minutes.
Apply twice daily (morning and night) until a healthy nail has fully grown out.
For athletes foot: Pay special attention to spaces between the toes,wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
For athlete's foot and jock itch, use daily for 4 weeks..This product is not effective on the scalp or nails. lf condition persistslonger, consult a doctor.

INACTIVE INGREDIENT SECTION

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
OREGANO OIL
CEYLON CINNAMON BARK OIL
LAVANDULA ANGUSTIFOLIA (LAVENDER) EXTRACT
CAPRYLIC/CAPRIC DIGLYCEROL SUCCINATE
ISOPROPYL MYRISTATE
TOCOPHEROL
BISABOLOL
PANTHENOL
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codesavilandofficial.com/label.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85966-00585966-005-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-02-24full-release2026-06-01 01:46:54

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nail Fungus Treatment PenUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe842e1-b3db-c003-e063-6394a90a46b82026-06-04WarningsExact identifier
ndc (package): 85966-005-01
ndc (product): 85966-005
ndc11 (package): 85966000501
spl id: 53693514-54f6-75ab-e063-6294a90a76eb
spl set id: 3fe842e1-b3db-c003-e063-6394a90a46b8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.