Lotrimin Ultra

Lotrimin Ultra
SPL v3
SPL
SPL Set ID 1b438ca7-fd5f-62cb-e063-6294a90ab3a6
Route
TOPICAL
Published
Effective Date 2024-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
NDA Active Since 2024-01-02

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • cures most ringworm
  • cures most jock itch
  • 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 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 ringworm and jock itch: apply once a day to affected skin for 2 weeks or as directed by a doctor
  • 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.
  • 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
Questions?

Questions? 1-866-360-3266 or visit us a www.lotrimin.com

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 30 G Tube Carton


Structured Label Content

Uses
  • cures most ringworm
  • cures most jock itch
  • 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 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 ringworm and jock itch: apply once a day to affected skin for 2 weeks or as directed by a doctor
  • 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.
  • 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
Questions?

Questions? 1-866-360-3266 or visit us a www.lotrimin.com

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 30 G Tube Carton (PRINCIPAL DISPLAY PANEL - 30 g Tube Carton)


Advanced Ingredient Data


Raw Label Data

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