FDA Label for Athletes Foot Ultra
View Indications, Usage & Precautions
Athletes Foot Ultra Product Label
The following document was submitted to the FDA by the labeler of this product H E B. 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.
Other
Drug Facts
Active Ingredient
Butenafine hydrochloride 1%
Purpose
Antifungal
Uses
- cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.
- cures most jock itch and ringworm
- relieves itching, burning, cracking, and scaling which accompany these conditions
Warnings
For external use only
Do Not Use
- on nails or scalp
- in or near the mouth or the eyes
- for vaginal yeast infections
Otc - When Using
When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if too much irritation occurs or irritation gets worse
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years and older:
- use the tip of the cap to break the seal and open the tube
- wash the affected skin with soap and water and dry completely before applying
- for athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
Apply between and around the toes
1 week twice a day or 4 weeks once a day - for jock itch and ringworm: apply once a day to affected skin for 2 weeks or as directed by a doctor.
- wash hands after each use
- children under 12 years: ask a doctor
Other Information
- do not use if seal on tube is broken or not visible
- store between 20° to 25° C (68° to 77° F)
Inactive Ingredients
benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum
Questions?
Call 1-866-923-4914
Principal Display Panel - 12 G Tube Carton
Compare to Lotrimin Ultra®* active ingredient
NDC 37808-013-02
H-E-B®
Clinically Proven to Cure Most Athlete's Foot between the Toes
Athlete's Foot Cream Ultra
Butenafine Hydrochloride Cream 1%
Antifungal
NET WT 12 g (0.42 oz)
* Please review the disclaimer below.