Jock Itch (Butenafine Hydrochloride) Cream [Taro Pharmaceuticals U.s.a., Inc.] -

JOCK ITCH (BUTENAFINE HYDROCHLORIDE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]
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NDC	51672-2101-1, 51672-2101-2, 51672-2101-8, 51672-2101-9
Set ID	14a23a39-b567-4db4-bac0-c008c0ca6171
Category	HUMAN OTC DRUG LABEL
Packager	Taro Pharmaceuticals U.S.A., inc.
Generic Name
Product Class	Benzylamine Antifungal
Product Number
Application Number	ANDA205181

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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 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
  - 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), propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum
Questions?

Call 1-866-923-4914
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Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

Clinically Proven to Cure Most Jock Itch

Butenafine
Hydrochloride Cream 1%

Antifungal
NET WT 15 g (0.53 oz)

INGREDIENTS AND APPEARANCE

JOCK ITCH
butenafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51672-2101
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)
glycerin (UNII: PDC6A3C0OX)
glyceryl stearate SE (UNII: FCZ5MH785I)
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)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51672-2101-8	1 in 1 CARTON	11/17/2017
1		12 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:51672-2101-1	1 in 1 CARTON	11/17/2017
2		15 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:51672-2101-9	1 in 1 CARTON	11/17/2017
3		24 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:51672-2101-2	1 in 1 CARTON	11/17/2017
4		30 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
ANDA	ANDA205181	11/17/2017

Labeler - Taro Pharmaceuticals U.S.A., inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(51672-2101)

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Medic

JOCK ITCH (BUTENAFINE HYDROCHLORIDE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]

Do not use

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