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Lotrimin Ultra

MSD Consumer Care, Inc.

Lotrimin Ultra Antifungal


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Butenafine hydrochloride 1%

Purpose

Antifungal

Lotrimin Ultra 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

Lotrimin Ultra 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

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)

Lotrimin Ultra

Lotrimin Ultra

Butenafine Hydrochloride CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11523-7154
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BUTENAFINE HYDROCHLORIDE Butenafine 10 mg

Inactive Ingredients

Ingredient Name Strength
BENZYL ALCOHOL
CETYL ALCOHOL
DIETHANOLAMINE
GLYCERIN
ceteth-23
propylene glycol dicaprylate
water
SODIUM BENZOATE
STEARIC ACID
petrolatum

Product Characteristics

Color
WHITE (White to off-white)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 TUBE
2 24 in 1 TUBE
3 30 in 1 TUBE
4 15 in 1 TUBE
5 NDC:11523-7154-4 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021307 1993-09-23


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