ATHLETES FOOT ULTRA- butenafine hydrochloride cream

Athletes Foot Ultra by

Drug Labeling and Warnings

Athletes Foot Ultra by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

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

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?

1-888-287-1915

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

NDC: 49035-225-08

equate™

Compare to
Lotrimin Ultra®
Active
Ingredient*

CONTAINS THE DRUG:
BUTENAFINE HYDROCHLORIDE

Athlete's
Foot
ULTRA

Butenafine
Hydrochloride
Cream 1%
Antifungal

Prescription Strength

1 Week
Treatment Option
For Athlete's Foot
See Directions

Clinically Proven To
Cure Most Athlete's
Foot Between The Toes

• Relieves Itching, Burning
  And Cracking

NET WT 0.42 OZ (12 g)

INGREDIENTS AND APPEARANCE

ATHLETES FOOT ULTRA 
butenafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-225
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Butenafine Hydrochloride (UNII: R8XA2029ZI) (Butenafine - UNII:91Y494NL0X)	Butenafine Hydrochloride	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
benzyl alcohol (UNII: LKG8494WBH)
cetyl alcohol (UNII: 936JST6JCN)
glycerin (UNII: PDC6A3C0OX)
glyceryl stearate SE (UNII: FCZ5MH785I)
ceteth-23 (UNII: 495CTZ441V)
propylene glycol dicaprylate (UNII: 581437HWX2)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
stearic acid (UNII: 4ELV7Z65AP)
trolamine (UNII: 9O3K93S3TK)
petrolatum (UNII: 4T6H12BN9U)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-225-08	1 in 1 CARTON	01/16/2019
1		12 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	ANDA205181	11/16/2017

Labeler - Wal-Mart Stores Inc (051957769)