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Dryello Dual Action Relief for Athlete Foot

Dryello Dual-Action Relief for Athlete's Foot - 2 x 0.53 oz Sticks

Approved
Approval ID

359478dd-02c9-05e5-e063-6294a90a41ed

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

ProPedix, Inc.

DUNS: 119483645

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tolnaftate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85565-002
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Tolnaftate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (13)

.ALPHA.-TOCOPHEROL ACETATE, DL-Inactive
Code: WR1WPI7EW8
Classification: IACT
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
MARANTA ARUNDINACEA ROOTInactive
Code: FVN346W31A
Classification: IACT
MAGNESIUM CITRATEInactive
Code: RHO26O1T9V
Classification: IACT
TOLNAFTATEActive
Quantity: 1 g in 100 g
Code: 06KB629TKV
Classification: ACTIB
BEHENYL BEHENATEInactive
Code: K8NU647RJ0
Classification: IACT
ORANGE OILInactive
Code: AKN3KSD11B
Classification: IACT
CYCLOPENTASILOXANEInactive
Code: 0THT5PCI0R
Classification: IACT
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
MAGNESIUM SULFATEInactive
Code: DE08037SAB
Classification: IACT
MAGNESIUM HYDROXIDEInactive
Code: NBZ3QY004S
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/20/2025

Principal Display Panel

Treats + Prevents

Dryello TM

TOLNAFTATE 1% ANTIFUNGAL

Dual-action relief for

Athlete's Foot

Two 15g (0.53oz) NET WT Sticks

Outer Packaging - Unit Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/20/2025

Uses

  • Cures most Athlete's Foot (tinea pedis)
  • Relieves itching, burning, cracking, and scaling
  • Prevents recurrence of most Athlete's foot with daily use

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/20/2025

Active Ingredient

Tolnaftate 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/20/2025

Purpose

Antifungal

WARNINGS SECTION

LOINC: 34071-1Updated: 5/20/2025

Warnings

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

For external use only. Avoid contact with eyes.

When using this product

  • If irritation occurs, discontinue use and consult a doctor

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/20/2025

Directions

  • Wash feet and dry thoroughly.
  • Apply a think layer of the product to the affected area twice daily (morning and night).
  • Supervise children in the use of this product.
  • Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/20/2025

Other

Store between 68º - 86ºF (20º - 30ºC)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/20/2025

Inactive ingredients

Aluminum Hydroxide, Arrowroot Powder, Behenyl Behenate, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Magnesium Aluminum Silicate, Magnesium Citrate, Magnesium Hydroxide, Magnesium Sulfate, Orange Peel Oil, Stearyl Alcohol, Tocopheryl Acetate.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/20/2025

Questions?

1-800-452-7362 dryello.com

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Dryello Dual Action Relief for Athlete Foot - FDA Drug Approval Details