TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride 1g in 100g cream

Terbinafine Hydrochloride by

Drug Labeling and Warnings

Terbinafine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Happy Foot Shop LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KEEP OUT OF REACH OF CHILDREN

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

Active Ingredient :

Terbinafine Hydrochloride 1%

Antifungal

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.

Storage and Handling

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

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.

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.

Questions about Product and Distribution

Distributed by :

Happy Foot Shop, LLC

Novato, CA 94947

800-659-3024

www.fungablend10.com

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

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)

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)

Product Box

INGREDIENTS AND APPEARANCE

TERBINAFINE HYDROCHLORIDE 
terbinafine hydrochloride 1g in 100g cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69983-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP)	TERBINAFINE HYDROCHLORIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CITRUS LIMON (LEMON) LEAF OIL (UNII: E090Y54IT5)
PHENOXYPROPANEDIOL (UNII: 38D39W41IJ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
STEARIC ACID D7 (UNII: T3B081197X)
ALOE BARBADENSIS LEAF JUICE POWDER (UNII: ZY81Z83H0X)
CALCIUM DISODIUM EDTA (UNII: 8U5D034955)
POLYMETHYLSILSESQUIOXANE (UNII: 59Z907ZB69)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERIN 1,3-DIMETHYL ETHER (UNII: A0JF0DT9XK)
LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL (UNII: ZBP1YXW0H8)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL STEARATE/PEG-75 STEARATE (UNII: 6PSS3TQ3UY)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL (UNII: 8LGU7VM393)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
MENTHOXYPROPANEDIOL (UNII: KD6TZ2QICH)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF (UNII: G43C57162K)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69983-027-02	1 in 1 CARTON	11/15/2024	03/31/2026
1		1 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077511	11/15/2024	03/31/2026

Labeler - Happy Foot Shop LLC (079776150)