athlete's foot ultra

athlete's foot ultra
SPL v2
SPL
SPL Set ID a77a2694-04e7-4b37-ac6a-34f896945912
Route
topical
Published
Effective Date 2019-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
butenafine (10 mg)
Inactive Ingredients
benzyl alcohol cetyl alcohol glycerin glyceryl stearate se ceteth-23 propylene glycol dicaprylate water sodium benzoate stearic acid trolamine petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
anda active Since 2017-11-16

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

Antifungal

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.

      Apply between and around the toes

      1 week twice a day or 4 weeks once a day
    • 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
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

Description

Drug Facts

Questions?

1-888-287-1915

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 iftoo much irritation occurs or irritation gets worse

Section 50567-7

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

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

Butenafine hydrochloride 1%

Principal Display Panel 12 G Tube Carton

NDC 49035-225-08

equate™

Compare to

Lotrimin Ultra®

Active

Ingredient*

CONTAINS THE DRUG:

BUTENAFINE HYDROCHLORIDE

Athlete's

Foot

ULTRA

Butenafine

Hydrochloride

Cream 1%

Antifungal

Prescription Strength

1 Week

Treatment Option

For Athlete's Foot

See Directions

Clinically Proven To

Cure Most Athlete's

Foot Between The Toes

  • Relieves Itching, Burning

    And Cracking

NET WT 0.42 OZ (12 g)


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

Antifungal

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.

      Apply between and around the toes

      1 week twice a day or 4 weeks once a day
    • 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
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

Questions?

1-888-287-1915

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 iftoo much irritation occurs or irritation gets worse

Section 50567-7 (50567-7)

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

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%

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

NDC 49035-225-08

equate™

Compare to

Lotrimin Ultra®

Active

Ingredient*

CONTAINS THE DRUG:

BUTENAFINE HYDROCHLORIDE

Athlete's

Foot

ULTRA

Butenafine

Hydrochloride

Cream 1%

Antifungal

Prescription Strength

1 Week

Treatment Option

For Athlete's Foot

See Directions

Clinically Proven To

Cure Most Athlete's

Foot Between The Toes

  • Relieves Itching, Burning

    And Cracking

NET WT 0.42 OZ (12 g)


Advanced Ingredient Data


Raw Label Data

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