LOTRIMIN ULTRA JOCK ITCH- butenafine hydrochloride cream 
Famar Montreal Inc

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Lotrimin Ultra ®



Jock Itch

Drug Facts

Active ingredient

Butenafine hydrochloride 1%

Purpose

Antifungal

Uses

  • cures most jock itch
  • relieves itching, burning, cracking, and scaling which accompany this condition

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 over:
    • 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
    • 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 12g

LOTRIMIN ULTRA  JOCK ITCH
butenafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69213-4339
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUTENAFINE HYDROCHLORIDE (UNII: R8XA2029ZI) (BUTENAFINE - UNII:91Y494NL0X) BUTENAFINE HYDROCHLORIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETETH-23 (UNII: 495CTZ441V)  
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Product Characteristics
Colorwhite (white to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69213-4339-11 in 1 CARTON02/22/2002
112 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69213-4339-21 in 1 CARTON02/22/2002
215 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02130702/22/2002
Labeler - Famar Montreal Inc (203565379)

Revised: 4/2017
Document Id: 4e3f5ab9-03ff-21ac-e054-00144ff88e88
Set id: 4e3f1b3f-f27f-577d-e054-00144ff8d46c
Version: 4
Effective Time: 20170428
 
Famar Montreal Inc