Lotrimin Ultra ®

Lotrimin Ultra ®
SPL v7
SPL
SPL Set ID d11dfdf6-9b36-03bc-e053-2995a90a0bc3
Route
TOPICAL
Published
Effective Date 2022-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Butenafine (1 g)
Inactive Ingredients
Stearic Acid Trolamine Glycerin White Petrolatum Benzyl Alcohol Cetyl Alcohol Water Sodium Benzoate Ceteth-23 Glyceryl Monostearate Propylene Glycol Dicaprylate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
NDA Active Since 2021-12-20

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.
  • relieves itching, burning, cracking, and scaling which accompany this condition
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

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

Section 50570-1
  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections
Section 51945-4

​LOTRIMIN ULTRA ®

BUTENAFINE HYDROCHLORIDE CREAM 1% ANTIFUNGAL



NET WT 20g (0.70 OZ)

Warnings

For external use only

Directions
  • adults and children 12 years and older:
    • wash the affected skin with soap and water and dry completely before applying
    • to open the applicator, twist the base to the ON position. Squeeze tube to dispense cream.
    • 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.
    • wipe applicator tip with a tissue and close the applicator by twisting the base to the OFF position
    • wash hands after each use
  • children under 12 years: ask a doctor
Questions?

1-866-360-3266 or visit us at www.lotrimin.com

Active Ingredient

Butenafine hydrochloride 1%

Other Information
  • 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


Structured Label Content

Uses
  • cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.
  • relieves itching, burning, cracking, and scaling which accompany this condition
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)
  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections
Section 51945-4 (51945-4)

​LOTRIMIN ULTRA ®

BUTENAFINE HYDROCHLORIDE CREAM 1% ANTIFUNGAL



NET WT 20g (0.70 OZ)

Purpose

Antifungal

Warnings

For external use only

Directions
  • adults and children 12 years and older:
    • wash the affected skin with soap and water and dry completely before applying
    • to open the applicator, twist the base to the ON position. Squeeze tube to dispense cream.
    • 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.
    • wipe applicator tip with a tissue and close the applicator by twisting the base to the OFF position
    • wash hands after each use
  • children under 12 years: ask a doctor
Questions?

1-866-360-3266 or visit us at www.lotrimin.com

Active Ingredient

Butenafine hydrochloride 1%

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)