Flawless Nails

Flawless Nails
SPL v1
SPL
SPL Set ID f1875a4f-fc46-cb91-e053-2995a90addeb
Route
TOPICAL
Published
Effective Date 2023-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Camphor (natural) Cinnamon Bark Oil Hippophae Rhamnoides Fruit Oil Trimethylpentanediol/adipic Acid/glycerin Crosspolymer (25000 Mpa.s) Pinene Almond Oil Peppermint Oil .alpha.-tocopherol Acetate Clove Lavender Oil Limonene, (+)- Alkyl (c12-15) Benzoate Tea Tree Oil Hippophae Rhamnoides Seed Oil Diethylene Glycol Monoethyl Ether Citronella Oil Ceramide 3 Olive Oil Oregano Leaf Oil Jojoba Oil Clove Oil Thymol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-04-03
Description

Tolnaftate

Medication Information

Warnings and Precautions

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.

Indications and Usage

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
Dosage and Administration

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

Description

Tolnaftate

Section 43683-2

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.

Section 50565-1

Keep out of reach of children.

Get medical help or contact a Poison Control Center right away

Section 50567-7

When using this product, avoid contact with the eyes

Section 50570-1

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

Section 51727-6

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.

Section 51945-4

FLAWLESS NAILS LABEL AND FLAWLESS NAILS BOX

Section 53413-1

MyFlawlessNails LLC

Fairfield, CT 06824

www.MyFlawlessNails.com

Section 55105-1

Antifungal

Section 55106-9

Tolnaftate

Section 60561-8

Other information: Store at 68° - 77°

Section 69718-5

FLAWLESS NAILS

Nail Fungus Eliminator

Medical Strength

Clinically Proven

15ML (O.5FL.OZ)

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Section 43683-2 (43683-2)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Get medical help or contact a Poison Control Center right away

Section 50567-7 (50567-7)

When using this product, avoid contact with the eyes

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

FLAWLESS NAILS LABEL AND FLAWLESS NAILS BOX

Section 53413-1 (53413-1)

MyFlawlessNails LLC

Fairfield, CT 06824

www.MyFlawlessNails.com

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Tolnaftate

Section 60561-8 (60561-8)

Other information: Store at 68° - 77°

Section 69718-5 (69718-5)

FLAWLESS NAILS

Nail Fungus Eliminator

Medical Strength

Clinically Proven

15ML (O.5FL.OZ)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:39.224900 · Updated: 2026-03-14T23:01:08.226420