OTC Medication Information: Lotrimin Ultra Athletes Foot

LOTRIMIN ULTRA ATHLETES FOOT- butenafine hydrochloride cream
Bayer Healthcare LLC.

Drug Facts

Active ingredient

Butenafine hydrochloride 1%

Purpose

Antifungal

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

Warnings

For external use only

Do not use

  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections

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

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

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

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

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

Distributed by Bayer HealthCare LLC, Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL — 12 g Tube Carton

LOTRIMIN ULTRA ®

butenafine hydrochloride cream 1%
ANTIFUNGAL
NET WT 12g (0.42 OZ)

Carton 12 g
(click image for full-size original)
LOTRIMIN ULTRA ATHLETES FOOT
butenafine hydrochloride cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-4338
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUTENAFINE HYDROCHLORIDE (BUTENAFINE) BUTENAFINE HYDROCHLORIDE 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
CETYL ALCOHOL
GLYCERIN
CETETH-23
PROPYLENE GLYCOL DICAPRYLATE
WATER
SODIUM BENZOATE
STEARIC ACID
TROLAMINE
PETROLATUM
Product Characteristics
Color white (white to off white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11523-4338-1 1 TUBE in 1 CARTON contains a TUBE
1 12 g in 1 TUBE This package is contained within the CARTON (11523-4338-1)
2 NDC:11523-4338-2 1 TUBE in 1 CARTON contains a TUBE
2 15 g in 1 TUBE This package is contained within the CARTON (11523-4338-2)
3 NDC:11523-4338-4 1 TUBE in 1 CARTON contains a TUBE
3 30 g in 1 TUBE This package is contained within the CARTON (11523-4338-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021307 02/22/2002
Labeler — Bayer Healthcare LLC. (112117283)

Revised: 11/2019 Bayer Healthcare LLC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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