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

Purpose

Antifungal

Description

Drug Facts


Medication Information

Warnings

For external use only

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
Purpose

Antifungal

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
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

Description

Drug Facts

Questions?

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

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)

Active Ingredient

Butenafine hydrochloride 1%


Structured Label Content

Warnings

For external use only

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
Purpose

Antifungal

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
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

Questions?

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

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)

Active Ingredient

Butenafine hydrochloride 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)