BUTENAFINE HYDROCHLORIDE cream

Butenafine Hydrochloride by

Drug Labeling and Warnings

Butenafine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by YYBA CORP, Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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 productdo not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor iftoo 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

    

  • 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 1-866-933-6337

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Distributed by:
Wellspring
Airmont, NY 10952, U.S.A.

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Butenafine
Hydrochloride Cream 1%

Antifungal
NET WT 30 g (1 oz)

INGREDIENTS AND APPEARANCE

BUTENAFINE HYDROCHLORIDE 
butenafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73581-210
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73581-210-02	1 in 1 CARTON	10/12/2023
1		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	10/12/2023

Labeler - YYBA CORP (006339772)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharma Canada Inc.		243339023	manufacture(73581-210)