DERMATOOL Fungal Nail Solution

Manufacturer
RENU LABORATORIES, INC.
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:17:37

Label at a glance#

ProductDERMATOOL Fungal Nail Solution
Active ingredientTOLNAFTATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Purpose

Antifungal

INDICATIONS & USAGE SECTION

Uses

  • Helps cure most fungal nail and skin infections, including Tinea Corporis (Ringworm) and Tinea Pedis (Athlete's Foot).
  • Effectively relieves itching, burning, cracking and scaling accompanying the above conditions.

RECENT MAJOR CHANGES SECTION

NO CHANGES AT ALL

WARNINGS SECTION

Warnings

For external use only

  • Do not use on children under 2 years of age unless directed by a doctor
  • Avoid contact with eyes, ears or mouth
  • Stop use and ask a physician if rash or irritation occurs

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • Shake well before each use
  • Wash and clean affected area and dry thoroughly
  • Use Dermatool implements to trim nails and lightly file down the nail plate surface
  • Wipe down the area clean. Do not bring nail debris onto brush or back into solution
  • Apply a thin layer of antifungal solution directly to affected areas twice daily (morning and night) especially important around the edges of the nail, cuticles and the space around the nails
  • Application to adjacent nails is recommended to prevent the spread of infection
  • Allow solution to soak into the nail or skin then air dry
  • Keep affected areas clean and dry throughout the day
  • Supervise children in the use of this product.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

C12-15 Alkyl Benzoate, Cannabis Sativa (Hemp) Seed Oil, Cinnamomum Zeylanicum (Cinnamon) Bark Oil, Ethoxydiglycol, Eucalyptol, Eugenia Caryophyllum (Clove) Extract, Hippophae Rhamnoides (Sea Berry) Fruit & Seed Oils, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Oreganum Vulgare (Oregano) Leaf Oil, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Tocopherol (Vitamin E), Trimethylpentanediol-Adipic Acid Copolymer

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1 percent

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Multi layer label and product box

Label outsideLabel outside

Label insideLabel insideBOX ARTBOX ART

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-58476348-584-05, 76348-584-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
017eb77a-fcf2-6c70-e063-6294a90a639bb20a1f5a-a9b2-057d-e053-2995a90a8a972023-07-27WarningsExact identifier
spl set id: b20a1f5a-a9b2-057d-e053-2995a90a8a97

Reported adverse events (FAERS/openFDA)#

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