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NDC 49035-0178-08 Butenafine Hydrochloride 10 mg/g Details

Butenafine Hydrochloride 10 mg/g

Butenafine Hydrochloride is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. The primary component is BUTENAFINE HYDROCHLORIDE.

Product Information

NDC	49035-0178
Product ID	49035-178_db3fd7a4-9c4e-4db3-b5ac-cc75fe1ecc9e
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	Butenafine Hydrochloride
Proprietary Name Suffix	Jock Itch
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	Wal-Mart Stores 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 49035-0178-08 (49035017808)

Pricing Information	N/A
NDC Package Code	49035-178-08
Billing NDC	49035017808
Package	1 TUBE in 1 CARTON (49035-178-08) / 12 g in 1 TUBE
Marketing Start Date	2018-12-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL be9a411c-55d7-4db5-a420-30013efbbc24 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) Cetyl Ether, Propylene Glycol Dicaprylate, Purified Water, Sodium Benzoate, Stearic Acid, Trolamine, White Petrolatum

Questions?

1-888-287-1915

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

Walmart Inc.,

Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

NDC 49035-178-08

equate™

Compare to Lotrimin Ultra® Jock Itch Active Ingredient*

CONTAINS THE DRUG:

BUTENAFINE HYDROCHLORIDE

Butenafine Hydrochloride Cream 1%

Antifungal

Clinically Proven To Cure Most Jock Itch

Prescription Strength
Relieves Itching, Burning and Chafing

NET WT

0.42 OZ (12 g)

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

INGREDIENTS AND APPEARANCE

BUTENAFINE HYDROCHLORIDE JOCK ITCH

butenafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-178
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:49035-178-08	1 in 1 CARTON	12/14/2018
1		12 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	11/16/2017

Labeler - Wal-Mart Stores Inc (051957769)

Revised: 1/2019

Document Id: db3fd7a4-9c4e-4db3-b5ac-cc75fe1ecc9e

Set id: be9a411c-55d7-4db5-a420-30013efbbc24

Version: 1

Effective Time: 20190107

Search by Drug Name or NDC

NDC 49035-0178-08 Butenafine Hydrochloride 10 mg/g Details

Butenafine Hydrochloride 10 mg/g

Product Information

Package

Package Images

NDC 49035-0178-08 (49035017808)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL be9a411c-55d7-4db5-a420-30013efbbc24 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Do not use

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

INGREDIENTS AND APPEARANCE

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