ATHLETES FOOT- butenafine hydrochloride cream

Athletes Foot by

Drug Labeling and Warnings

Athletes Foot by is a Otc medication manufactured, distributed, or labeled by Sun Pharmaceutical Industries, Inc., Sun Pharma Canada 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?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

Clinically Proven to Cure Most Athlete's Foot between the Toes

Butenafine
Hydrochloride Cream 1%

Antifungal
NET WT 15 g (0.53 oz)

INGREDIENTS AND APPEARANCE

ATHLETES FOOT 
butenafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51672-2100
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)
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: 51672-2100-8	1 in 1 CARTON	11/17/2017
1		12 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51672-2100-1	1 in 1 CARTON	11/17/2017
2		15 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 51672-2100-9	1 in 1 CARTON	11/17/2017
3		24 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 51672-2100-2	1 in 1 CARTON	11/17/2017
4		30 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	11/17/2017

Labeler - Taro Pharmaceuticals U.S.A., inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(51672-2100)