Terbinafine Hydrochloride

Manufacturer
Happy Foot Shop LLC
Effective date
2024-10-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:41:34

Label at a glance#

ProductTerbinafine Hydrochloride
Active ingredientTERBINAFINE HYDROCHLORIDE
Label structure12 sections

Dosage and administration

Directions : Adults and Children ( 12 years and over ) : Wash the affected skin with soap and water. Dry completely before applying. For Athlete's Foot use : Apply a thin layer twice a day (AM & PM) on the affected area, for 2 weeks or as directed by a physician. Wear ventilated shoes and change socks and shoes daily. Wash hands after application. For Jock Itch and Ring Worm : Apply a thin layer covering area affe...

Storage and handling

Store at room temperature between 20-25°C ( 68-77°F)

Label contents#

Full prescribing information#

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

For External Use Only

Do Not Use : On Nails, Scalp, Near Eyes or Mouth or For Vaginal Yeast Infections.

When using ths Product : Do not get into eyes. If eye contact occurs, rinse throughly with water.

Stop use and ask a doctor if : too much irritation occurs or gets worse.

Keep out of reach of children.

If swallowed , seek medical help or contact Poison Control Center (800) 222-1222

(POISONHELP.ORG)

Terbinafine Hydrochloride 1% ...................Antifungal

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient :

Terbinafine Hydrochloride 1%

Antifungal

Indications & Usage

INDICATIONS & USAGE SECTION

Uses :

  • Cures most Athlete;s Foot ( Tinea Pedis)
  • Cures most Jock Itch ( Tinea Pedis)
  • Cures most Ring Worm ( Tinea Corporis)

Provides relief from itching, burning, cracking and scalingwhich accompany these conditions.

Storage and Handling

STORAGE AND HANDLING SECTION

Store at room temperature between 20-25°C ( 68-77°F)

Directions

DOSAGE & ADMINISTRATION SECTION

Directions :

Adults and Children ( 12 years and over ) : Wash the affected skin with soap and water. Dry completely before applying.

For Athlete's Foot use : Apply a thin layer twice a day (AM & PM) on the affected area, for 2 weeks or as directed by a physician. Wear ventilated shoes and change socks and shoes daily. Wash hands after application.

For Jock Itch and Ring Worm : Apply a thin layer covering area affected, once a day for 1 week or as directed by a physician. Wash hands after application, unless treating hands for infection. Keep treated hands off face and eyes.

Continue to use FungaBlend10® Athlete's Foot Cream until the full treatment period is finished, even if symptoms disappear after a few days. Stopping this medication too early may result in a return of the infection.

Seek Medical Treatment

OTC - STOP USE SECTION

Seek Medical Treatment if your condition worsens or does not improve within 4 weeks for Athlete's Foot and within 2 weeks for Jock Itch and Ringworm.

Questions about Product and Distribution

OTC - QUESTIONS SECTION

Distributed by :

Happy Foot Shop, LLC

Novato, CA 94947

800-659-3024

www.fungablend10.com

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Distilled Water

Isopropyl Myristate

Aloe Barbadensis Leaf Juice Powder

Disodium EDTA

Glycerin

Allatoin

Xanthan Gum

Stearic Acid

Cetyl Alcohol

Glyceryl Stearate

Sodium Acrylate/Sodium Acryloydimethyl

Polymethylsilsesquioxane

Dimethicone

Sodium Hyaluronate Crosspolymer

Propylene Glycol

Citris Medica Limonum(Lemon) Oil

Lavandula Officinalis (Lavender) Oil

Melaleuca Altenafolia (Tea Tree) Oil

Rosmarinus Officinalis (Rosemary) Leaf Oil

Thymus Vulgarus (Thyme) Leaf Oil

Phenoxyethanol , Ethylhexlglycerin

Menthoxypropanediol

Sodium Hydroxide

Purpose

OTC - PURPOSE SECTION

Antifungal

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

DO NOT USE ON : On Nails, Scalp, Near Eyes or Mouth or For Vaginal Yeast Infections.

When using this product: Do not get into eyes. If eye contact occurs, rinse throughly with water .

Stop use and ask a doctor if : too much irritation occurs or gets worse.

Keep Out of reach of Children. If swallowed, seek medical help or contact Poison Control Center (800) 222-1222

(POISONHELP.ORG)

FungaBlend 10® Athlete's Foot Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FungaBlend 10®

ATHLETE'S FOOT CREAM

For Topical Use Only

TERBINAFINE HYDROCHLORIDE CREAM 1%

ANTIFUNGAL THERAPY

PODIATRIST DEVELOPED

PROFESSIONAL STRENGTH

Made with 10 Potent Plant Medicines

2 FL OZ (60ML)

Product Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product boxProduct box

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69983-027TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE 1G IN 100G) CREAM [HAPPY FOOT SHOP LLC]1Unmatched20250206_25ba24d1-b228-8843-e063-6294a90a15bb.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69983-02769983-027-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

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
25ba24d1-b229-8843-e063-6294a90a15bb25ba24d1-b228-8843-e063-6294a90a15bb2024-10-30WarningsExact identifier
spl id: 25ba24d1-b229-8843-e063-6294a90a15bb
spl set id: 25ba24d1-b228-8843-e063-6294a90a15bb

Reported adverse events (FAERS/openFDA)#

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