Lotrimin Ultra ®

Lotrimin Ultra ®
SPL v11
SPL
SPL Set ID e258c4ac-53ef-4a99-b732-4985f890b938
Route
TOPICAL
Published
Effective Date 2015-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
NDA Active Since 2002-02-22

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.
  • cures most jock itch and ringworm
  • relieves itching, burning, cracking, and scaling which accompany these conditions
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.

Warnings

For external use only

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
Do Not Use
  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections
Active Ingredient

Butenafine hydrochloride 1%

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

Principal Display Panel 12 G Tube Carton

LOTRIMIN ULTRA ®

butenafine hydrochloride cream 1%



ANTIFUNGAL



NET WT 12g (0.42 OZ)


Structured Label Content

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
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.

Purpose

Antifungal

Warnings

For external use only

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
Do Not Use (Do not use)
  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections
Active Ingredient (Active ingredient)

Butenafine hydrochloride 1%

Other Information (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 (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

Principal Display Panel 12 G Tube Carton (PRINCIPAL DISPLAY PANEL - 12 g Tube Carton)

LOTRIMIN ULTRA ®

butenafine hydrochloride cream 1%



ANTIFUNGAL



NET WT 12g (0.42 OZ)


Advanced Ingredient Data


Raw Label Data

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