LOTRIMIN ULTRA ANTIFUNGAL- butenafine hydrochloride cream

Lotrimin Ultra by

Drug Labeling and Warnings

Lotrimin Ultra by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. 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.
  • 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, diethanolamine, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, white petrolatum

Questions?

866-360-3226

SPL UNCLASSIFIED SECTION

Distributed by MSD Consumer Care, Inc., PO Box 377, Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 30g Tube Carton

LOTRIMIN ULTRA®

butenafine hydrochloride cream 1%
ANTIFUNGAL
NET WT 30g (1.1 OZ)

INGREDIENTS AND APPEARANCE

LOTRIMIN ULTRA  ANTIFUNGAL
butenafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7154
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)
DIETHANOLAMINE (UNII: AZE05TDV2V)
GLYCERIN (UNII: PDC6A3C0OX)
CETETH-23 (UNII: 495CTZ441V)
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white (White to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7154-1	1 in 1 CARTON	02/22/2002	09/01/2017
1		12 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11523-7154-2	1 in 1 CARTON	02/22/2002	09/01/2017
2		24 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11523-7154-3	1 in 1 CARTON	02/22/2002	09/01/2017
3		30 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 11523-7154-4	1 in 1 CARTON	02/01/2002	09/01/2017
4		15 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
NDA	NDA021307	09/23/1993

Labeler - Bayer HealthCare LLC. (112117283)