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NDC 51672-2101-02 Jock Itch 10 mg/g Details

Jock Itch 10 mg/g

Jock Itch is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Taro Pharmaceuticals U.S.A., inc.. The primary component is BUTENAFINE HYDROCHLORIDE.

Product Information

NDC	51672-2101
Product ID	51672-2101_a0159f92-c609-486b-a727-bc4d431ed8eb
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Jock Itch
Proprietary Name Suffix	n/a
Non-Proprietary Name	Butenafine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/g
Substance Name	BUTENAFINE HYDROCHLORIDE
Labeler Name	Taro Pharmaceuticals U.S.A., inc.
Pharmaceutical Class	Benzylamine Antifungal [EPC], Benzylamines [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA205181
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51672-2101-02 (51672210102)

Pricing Information	N/A
NDC Package Code	51672-2101-2
Billing NDC	51672210102
Package	1 TUBE in 1 CARTON (51672-2101-2) / 30 g in 1 TUBE
Marketing Start Date	2017-11-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 14a23a39-b567-4db4-bac0-c008c0ca6171 Details

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 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

SPL UNCLASSIFIED SECTION

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)

Principal Display Panel - 15 g Tube Carton

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)

Revised: 11/2017

Document Id: a0159f92-c609-486b-a727-bc4d431ed8eb

Set id: 14a23a39-b567-4db4-bac0-c008c0ca6171

Version: 4

Effective Time: 20171120

Search by Drug Name or NDC

NDC 51672-2101-02 Jock Itch 10 mg/g Details

Jock Itch 10 mg/g

Product Information

Package

Package Images

NDC 51672-2101-02 (51672210102)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 14a23a39-b567-4db4-bac0-c008c0ca6171 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Do not use

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

INGREDIENTS AND APPEARANCE

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