SPL v1
SPL
SPL Set ID 25ba24d1-b228-8843-e063-6294a90a15bb
Route
TOPICAL
Published
Effective Date 2024-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Terbinafine (1 g)
Inactive Ingredients
Citrus Limon (lemon) Leaf Oil Phenoxypropanediol Sodium Hydroxide Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer Isopropyl Myristate Stearic Acid D7 Aloe Barbadensis Leaf Juice Powder Calcium Disodium Edta Polymethylsilsesquioxane Allantoin Glycerin 1,3-dimethyl Ether Lavandula Angustifolia (lavender) Oil Propylene Glycol Glyceryl Stearate/peg-75 Stearate Dimethicone Crosspolymer Rosmarinus Officinalis (rosemary) Leaf Oil Thymus Vulgaris Leaf Water Xanthan Gum Menthoxypropanediol Cetyl Alcohol Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Melaleuca Alternifolia (tea Tree) Leaf

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Completed Since 2024-11-15 Until 2026-03-31

Description

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)

Purpose

Antifungal

Storage and Handling

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


Medication Information

Purpose

Antifungal

Storage and Handling

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

Description

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)

Section 50565-1

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)

Warnings

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)

Directions

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.

Product Box

Indications & Usage

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.

Inactive Ingredients

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

Seek Medical Treatment

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.

Fungablend 10® Athlete's Foot Cream

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)

Questions About Product and Distribution

Distributed by :

Happy Foot Shop, LLC

Novato, CA 94947

800-659-3024

www.fungablend10.com

Terbinafine Hydrochloride 1% ...................antifungal

Active Ingredient :

Terbinafine Hydrochloride 1%

Antifungal


Structured Label Content

Section 50565-1 (50565-1)

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)

Purpose

Antifungal

Warnings

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)

Directions

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.

Product Box

Indications & Usage

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.

Inactive Ingredients

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

Storage and Handling

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

Seek Medical Treatment

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.

Fungablend 10® Athlete's Foot Cream (FungaBlend 10® Athlete's Foot Cream)

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)

Questions About Product and Distribution (Questions about Product and Distribution)

Distributed by :

Happy Foot Shop, LLC

Novato, CA 94947

800-659-3024

www.fungablend10.com

Terbinafine Hydrochloride 1% ...................antifungal (Terbinafine Hydrochloride 1% ...................Antifungal)

Active Ingredient :

Terbinafine Hydrochloride 1%

Antifungal


Advanced Ingredient Data


Raw Label Data

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