85966-010 EXTRA STRENGTH TOENAIIL RENEWAL PEN

Manufacturer
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | Guangzhou Meixi Biotechnology Co., Ltd.
Effective date
2026-04-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:59

Label at a glance#

ProductEXTRA STRENGTH TOENAIIL RENEWAL PEN
Active ingredientTOLNAFTATE, UNDECYLENIC ACID
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 effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch.
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. If 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 pen base until the brush tip is saturated with essence.
Apply a thin layer to the entire nail, including the nail edges and underneath the nail crevices. Let it dy for 2-3 minutes.

Apply twice daily (morning and night) until a healthy nail has fully grown out.
For athlete's 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 ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer,
consult a doctor. This product is not effective on the scalp or nails.

INACTIVE INGREDIENT SECTION

DIMETHYL ISOSORBIDE
UREA
SALICYLIC ACID
MANUKA OIL
OREGANO LEAF OIL
TEA TREE OIL
CLOVE OIL
THYME OIL
ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT
CINNAMON OIL
KERATIN, TYPE I CYTOSKELETAL 18
BIOTIN
LEVOMENOL
CENTELLA ASIATICA WHOLE
TOCOPHEROL
MENTHOL
PROPANEDIOL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN1
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD1
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codesavilandofficial.com/label1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85966-010-01EXTRA STRENGTH TOENAIIL RENEWAL PEN5 mL in 1 BOTTLELIQUID51

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85966-01085966-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

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
EXTRA STRENGTH TOENAIIL RENEWAL PENUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eea5ee7-0ef9-8d34-e063-6294a90af5952026-04-07WarningsExact identifier
ndc (package): 85966-010-01
ndc (product): 85966-010
ndc11 (package): 85966001001
spl id: 4eea5ee7-0efa-8d34-e063-6294a90af595
spl set id: 4eea5ee7-0ef9-8d34-e063-6294a90af595

Reported adverse events (FAERS/openFDA)#

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