FDA.reportPublic FDA data

Nail Renovar Plus

Manufacturer
SOHM, Inc
Effective date
2026-01-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-06-03 17:52:08

Label at a glance#

ProductNail Renovar Plus
Active ingredientTOLNAFTATE
Label structure11 sections

Indications and uses

Proven effective in the treatment of: Athlete's foot (tinea pedis) Jock itch (tinea cruris) Ringworm (tinea corporis)

Dosage and administration

Wash the affected are with soap and water, then dry thoroughly. Apply a thin layer of product over the affected area twice daily (morning and night) or as directed by a doctor. Supervise children during use. For Athlete's foot: Use daily for 4 weeks. Pay special attention to spaces between toes Wear well-fitting, ventilated shoes Change shoes and socks at least once daily For ringworm:  Use daily for 4 weeks. For ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose 

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

Proven effective in the treatment of:

  • Athlete's foot (tinea pedis)
  • Jock itch (tinea cruris)
  • Ringworm (tinea corporis)

Warnings

WARNINGS SECTION

  • For External use only.
  • Avoid contact with eyes.
  • Do not use on children under 2 years of age unless directed by a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children. If accidental ingestion occurs, get medical help or contact a Poison Control Center right away. 

Stop use and ask a doctor if 

OTC - STOP USE SECTION

  • Irritation occurs 
  • There is no improvement within 4 weeks for athlete's foot or ringworm.
  • There is no improvement within 2 weeks for jock itch.

Directions 

DOSAGE & ADMINISTRATION SECTION

  • Wash the affected are with soap and water, then dry thoroughly.
  • Apply a thin layer of product over the affected area twice daily (morning and night) or as directed by a doctor.
  • Supervise children during use.

For Athlete's foot: Use daily for 4 weeks.

  • Pay special attention to spaces between toes
  • Wear well-fitting, ventilated shoes
  • Change shoes and socks at least once daily

For ringworm:  Use daily for 4 weeks.

For jock itch: Use daily for 2 weeks.

  • If condition persists longer, consult a doctor
  • Not effective on the scalp or nails.
  • Not for the treatment of infected fingernails or toenails 
  • Not effective against bacteria or viruses

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Sweet Almond oil, Citronella oil, Lavender oil, Tea Tree Oil, Jojoba oil, Clove Bud Oil, Neem oil, Vitamin E (Tocopheryl Acetate)

Other Information

OTHER SAFETY INFORMATION

  • SHAKE WELL BEFORE USE
  • Store at room temperature 15°C -30 °C (59°-86°F)
  • Protect from freezing; if freezing occurs, warm to room temperature
  • Keep tightly closed when not in use

Questions ?

OTC - QUESTIONS SECTION

1-800-284-1524 or info@sohm.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nail Renovar Plus LabelNail Renovar Plus Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313423tolnaftate 1 % Topical SolutionPSN1
313423tolnaftate 10 MG/ML Topical SolutionSCD1
313423tolnaftate 1 % Topical SolutionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130350405100028GTIN-13: 0350405100028
EAN-13: 0350405100028
GTIN-12: 350405100028
UPC-A: 350405100028
GTIN storage (14 digits): 00350405100028		Nail Renovar Plus Label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50405-030-02Nail Renovar Plus15 mL in 1 BOTTLE, WITH APPLICATORLIQUID151

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50405-03050405-030-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
ALMOND OIL66YXD4DKO9IACT
CITRONELLA OILQYO8Q067D0IACT
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
JOJOBA OIL724GKU717MIACT
CLOVE OIL578389D6D0IACT
AZADIRACHTA INDICA SEED OIL4DKJ9B3K2TIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT

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
Nail Renovar PlusTOLNAFTATESOHM, Inc2c09925c-e63e-4d9b-8d76-b06bd2cba26c2026-01-02WarningsExact identifier
ndc (package): 50405-030-02
ndc (product): 50405-030
ndc11 (package): 50405003002
spl id: 4a9a4c07-97ee-43bb-9c7e-613d7ba80c29
spl set id: 2c09925c-e63e-4d9b-8d76-b06bd2cba26c

Reported adverse events (FAERS/openFDA)#

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