FDA.reportPublic FDA data

NAIL RENU ANTIFUNGAL SOLUTION

Manufacturer
RENU LABORATORIES, INC.
Effective date
2023-03-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:38

Label at a glance#

ProductNail Renu
Active ingredientTOLNAFTATE
Label structure15 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Purpose

Antifungal

INDICATIONS & USAGE SECTION

Uses

  • proven clinically to cure most Fungal nail and Skin infections including athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • Effectively relieves itching, burning, cracking and scaling associated with the above conditions.
  • helps prevent most athlete's foot from coming back with daily use

WARNINGS SECTION

Warnings

  • For external use only.

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, nose, and mouth.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks
  • if swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

OTC - PREGNANCY OR BREAST FEEDING SECTION

If Pregnant or breastfeeding ask a health professional before use.

INSTRUCTIONS FOR USE SECTION

Directions:

  • clean the affected area and dry thoroughly
  • apply a thin layer over the affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • use daily for 4 weeks. If condition lasts longer, ask a doctor
  • to prevent athlete's foot, apply to the feet once or twice daily
  • this product is not intended for/or effective on the scalp.

OTHER SAFETY INFORMATION

Other information

  • Store at 68º - 77º (20º - 25º C)

INACTIVE INGREDIENT SECTION

Inactive Ingredients

C12-15 Alkyl Benzoate, Camphor, Ceramide III, Cinnamonum Zeylanicum (Cinnamon) Bark Oil, Cymbopogon Nardus (Citronella) Oil, Ethoxydiglycol, Eugenia Caryophyllum (Clove) Bud Extract, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oils, Lavandula Angustifolia (Lavender) Oil, Limonene, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive Pomace) Oil, Oreganum Vulgare (Oregano) Leaf Oil, Pinene, Prunus Amygdallus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzgium Aromatique (Clove) Bud Oil, Thymol, Tocopherol (Vitamin E), Trimethylpentanediol-Adipic Acid Copolymer

DOSAGE & ADMINISTRATION SECTION

Directions

  • clean the affected area and dry thoroughly
    apply a thin layer over the affected area twice daily (morning and night)

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nail RENU LABEL ART

AND

NAIL RENU

BOX ART

NRFungal Label 2NRFungal Label 2

NailRenu BoxNailRenu Box

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-995-012025-01-30C16284748780-12cef2736-acf0-d83d-e063-dadaa90ab31fNAIL RENU ANTIFUNGAL SOLUTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-995-01Nail Renu1 in 1 BOXSOLUTION11
76348-995-05Nail Renu15 mL in 1 BOTTLE, GLASSSOLUTION151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-995NAIL RENU (TOLNAFTATE 1%) SOLUTION [RENU LABORATORIES, INC.]12 package rows20230406_f1877b83-30fc-7c8f-e053-2a95a90a7d1b.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-99576348-995-05, 76348-995-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
CERAMIDE 34370DF050BIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CLOVE OIL578389D6D0IACT
THYMOL3J50XA376EIACT
CITRONELLA OILQYO8Q067D0IACT
CLOVEK48IKT5321IACT
TEA TREE OILVIF565UC2GIACT
CINNAMON BARK OILXE54U569ECIACT
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)587WKM3S9QIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
OREGANO LEAF OIL7D0CGR40U1IACT
LAVENDER OILZBP1YXW0H8IACT
LIMONENE, (+)-GFD7C86Q1WIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PINENE996299PUKBIACT
JOJOBA OIL724GKU717MIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
PEPPERMINT OILAV092KU4JHIACT
OLIVE OIL6UYK2W1W1EIACT
ALMOND OIL66YXD4DKO9IACT

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
f1877b83-30fd-7c8f-e053-2a95a90a7d1bf1877b83-30fc-7c8f-e053-2a95a90a7d1b2023-03-22WarningsExact identifier
spl id: f1877b83-30fd-7c8f-e053-2a95a90a7d1b
spl set id: f1877b83-30fc-7c8f-e053-2a95a90a7d1b

Reported adverse events (FAERS/openFDA)#

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