FDA.reportPublic FDA data

FLAWLESS NAILS

Manufacturer
RENU LABORATORIES, INC. | RENU LABORATORIES
Effective date
2023-01-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:41

Label at a glance#

ProductFLAWLESS NAILS
Active ingredientTOLNAFTATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate

STATEMENT OF IDENTITY SECTION

FLAWLESS NAILS

Nail Fungus Eliminator

Medical Strength

Clinically Proven

15ML (O.5FL.OZ)

RECENT MAJOR CHANGES SECTION

No major changes in Directions. We forgot to save the section and had to retype it.

Only changes made in Dosage were the removal of bullets and unapproved punctuation.

OTHER SAFETY INFORMATION

Other information: Store at 68° - 77°

INACTIVE INGREDIENT SECTION

Inactive Ingredients

C12-15 Alkyl Benzoate, Camphor, Ceramide III, Cinnamonium 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 Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzgium Aromaticum (Clove Bud) Oil, Thymol, Tocopherol Acetate, Trimethyl-Adipic Acid Copolymer.

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

Uses

  • proven clinically to cure most:
  • athlete's foot (tinea pedis)
  • ringworm (tinea corporis)
  • Effectively soothes and relieves:
  • itching
  • burning
  • cracking
  • helps prevent most athlete's foot from coming back with daily use

WARNINGS SECTION

Warnings

For external use only

Do not use on children under 2 years of age unless directed by a doctor

When using this product avoid contact with the eyes

Stop use and ask a doctor if

  • there is no improvement within 4 weeks

Keep out of reach of children.

Get medical help or contact a Poison Control Center right away.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions

clean the affected area and dry thoroughly

apply a thin layer over the affected area twice daily

supervise children in the use of this product

for athletes foot pay special attention to the spaces between toes

use daily for 4 weeks

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FLAWLESS NAILS LABEL AND FLAWLESS NAILS BOX

FLAWLESS NAILS BOXFLAWLESS NAILS BOX

FLAWLESS NAIL LABELFLAWLESS NAIL 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

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
76348-990-022025-01-30C16284748780-12cef2736-7a49-d83d-e063-dadaa90ab31fFlawless Nails

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-990-01FLAWLESS NAILS15 mL in 1 BOTTLE, GLASSSOLUTION151
76348-990-02FLAWLESS NAILS1 in 1 BOXSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-990FLAWLESS NAILS (TOLNAFTATE) SOLUTION [RENU LABORATORIES, INC.]12 package rows20230411_f1875a4f-fc46-cb91-e053-2995a90addeb.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-99076348-990-01, 76348-990-02

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
CAMPHOR (NATURAL)N20HL7Q941IACT
CINNAMON BARK OILXE54U569ECIACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)587WKM3S9QIACT
PINENE996299PUKBIACT
ALMOND OIL66YXD4DKO9IACT
PEPPERMINT OILAV092KU4JHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TOLNAFTATE06KB629TKVACTIB
CLOVEK48IKT5321IACT
LAVENDER OILZBP1YXW0H8IACT
LIMONENE, (+)-GFD7C86Q1WIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
TEA TREE OILVIF565UC2GIACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
CITRONELLA OILQYO8Q067D0IACT
CERAMIDE 34370DF050BIACT
OLIVE OIL6UYK2W1W1EIACT
OREGANO LEAF OIL7D0CGR40U1IACT
JOJOBA OIL724GKU717MIACT
CLOVE OIL578389D6D0IACT
THYMOL3J50XA376EIACT

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
f1875a4f-fc47-cb91-e053-2995a90addebf1875a4f-fc46-cb91-e053-2995a90addeb2023-01-05WarningsExact identifier
spl id: f1875a4f-fc47-cb91-e053-2995a90addeb
spl set id: f1875a4f-fc46-cb91-e053-2995a90addeb

Reported adverse events (FAERS/openFDA)#

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