85966-011 EXTRA STRENGTH TOENAIIL RENEWAL SOLUTION

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 Solution
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 effective treatment of most athletes 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

Wash the affected area and dry thoroughly. File the nail surface to remove thickness. Clean the nail file after each use.
Using a disposable cotton swab or dropper to apply.
Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product.
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

UREA
DIETHYLENE GLYCOL MONOETHYL ETHER
ALOE VERA LEAF
SALICYLIC ACID
TEA TREE OIL
OREGANO LEAF OIL
MANUKA OIL
ALLSPICE LEAF OIL
THYMUS VULGARIS (THYME) LEAF EXTRACT
BIOTIN
MENTHOL
JEEN VITAMIN E JEEN
LEVOMENOL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label2label2

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/label2.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85966-011-01EXTRA STRENGTH TOENAIIL RENEWAL Solution1 in 1 BOXLIQUID11
85966-011-01EXTRA STRENGTH TOENAIIL RENEWAL Solution30 mL in 1 BOTTLELIQUID301
85966-011-02EXTRA STRENGTH TOENAIIL RENEWAL Solution2 in 1 BOXLIQUID21
85966-011-02EXTRA STRENGTH TOENAIIL RENEWAL Solution30 mL in 1 BOTTLELIQUID301

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85966-01185966-011-01, 85966-011-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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 SolutionUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eeaa2f0-efc7-eab3-e063-6294a90a13b32026-04-07WarningsExact identifier
ndc (package): 85966-011-01
ndc (package): 85966-011-02
ndc (product): 85966-011
ndc11 (package): 85966001101
ndc11 (package): 85966001102
spl id: 4eeaa2f0-efc8-eab3-e063-6294a90a13b3
spl set id: 4eeaa2f0-efc7-eab3-e063-6294a90a13b3

Reported adverse events (FAERS/openFDA)#

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