85966-017 SSPROTIP X Extra Strength Toenail Renewal Solution

Manufacturer
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | Guangzhou Meixi Biotechnology Co., Ltd.
Effective date
2026-05-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:58:27

Label at a glance#

ProductSSPROTIP X Extra Strength Toenail Renewal Solution
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 the affected nail 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 solution over affected area twice daily (morning and night). Supervise children in the use of this product.
Wait 2-3 minutes for the solution to be fully absorbed.
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 jock itch, use daily for 4 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

INACTIVE INGREDIENT SECTION

UREA
ETHOXYDIGLYCOL
DIMETHYL SULFONE
LACTIC ACID
MANUKA OIL
CLOVE BUD OIL
EUCALYPTUS GLOBULUS LEAF OIL
TEA TREE OIL
OREGANO OIL
SALICYLIC ACID
SQUALANE
SIMMONDSIA CHINENSIS
BIOTIN
TOCOPHERYL ACETATE
AQUA
ETHYLHEXYLGLYCERIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label4label4

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85966-017-01SSPROTIP X Extra Strength Toenail Renewal Solution1 in 1 BOXLIQUID11
85966-017-01SSPROTIP X Extra Strength Toenail Renewal Solution30 mL in 1 BOTTLELIQUID301
85966-017-02SSPROTIP X Extra Strength Toenail Renewal Solution30 mL in 1 BOTTLELIQUID301
85966-017-02SSPROTIP X Extra Strength Toenail Renewal Solution2 in 1 BOXLIQUID21

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85966-01785966-017-01, 85966-017-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
SSPROTIP X Extra Strength Toenail Renewal SolutionTOLNAFTATE,UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52519110-a3c9-21da-e063-6294a90abbce2026-05-21WarningsExact identifier
ndc (package): 85966-017-02
ndc (package): 85966-017-01
ndc (product): 85966-017
ndc11 (package): 85966001701
ndc11 (package): 85966001702
spl id: 52519110-a3ca-21da-e063-6294a90abbce
spl set id: 52519110-a3c9-21da-e063-6294a90abbce

Reported adverse events (FAERS/openFDA)#

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