Lotrimin Ultra Jock Itch Antifungal (Butenafine Hydrochloride) Cream [Bayer Healthcare Llc.] -

LOTRIMIN ULTRA JOCK ITCH ANTIFUNGAL (BUTENAFINE HYDROCHLORIDE) CREAM [BAYER HEALTHCARE LLC.]
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NDC	11523-7155-1, 11523-7155-2
Set ID	36f09b0c-454a-4489-92be-8e6902874a74
Category	HUMAN OTC DRUG LABEL
Packager	Bayer HealthCare LLC.
Generic Name
Product Class	Benzylamine Antifungal
Product Number
Application Number	NDA021307

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SPL UNCLASSIFIED SECTION

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, diethanolamine, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, white petrolatum
Questions:?

1-800-360-3226
SPL UNCLASSIFIED SECTION

Distributed by MSD Consumer Care, Inc., PO Box 377, Memphis, TN 38151 USA, a subsidiary of Merck & Co.,Inc., Whitehouse Station, NJ USA.
PRINCIPAL DISPLAY PANEL - 12g Tube Carton

LOTRIMIN ULTRA ®

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

INGREDIENTS AND APPEARANCE

LOTRIMIN ULTRA JOCK ITCH ANTIFUNGAL
butenafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-7155
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUTENAFINE HYDROCHLORIDE (UNII: R8XA2029ZI) (BUTENAFINE - UNII:91Y494NL0X)	BUTENAFINE HYDROCHLORIDE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIETHANOLAMINE (UNII: AZE05TDV2V)
GLYCERIN (UNII: PDC6A3C0OX)
CETETH-23 (UNII: 495CTZ441V)
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white (White to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11523-7155-1	1 in 1 CARTON	02/22/2002	09/01/2017
1		12 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11523-7155-2	1 in 1 CARTON	02/22/2002	09/01/2017
2		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021307	09/23/1993

Labeler - Bayer HealthCare LLC. (112117283)

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LOTRIMIN ULTRA JOCK ITCH ANTIFUNGAL (BUTENAFINE HYDROCHLORIDE) CREAM [BAYER HEALTHCARE LLC.]

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