FDA Label for Terbinafine Hydrochloride
View Indications, Usage & Precautions
Terbinafine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Happy Foot Shop Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - 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)
* Please review the disclaimer below.
