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NDC 00363-2080-02 Walgreens 1 g/100g Details

Walgreens 1 g/100g

Walgreens is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is TERBINAFINE HYDROCHLORIDE.

Product Information

NDC	00363-2080
Product ID	0363-2080_d8005a9c-424b-4d89-a6da-a64bfd04cbf5
Associated GPIs
GCN Sequence Number	018273
GCN Sequence Number Description	terbinafine HCl CREAM (G) 1 % TOPICAL
HIC3	Q5F
HIC3 Description	TOPICAL ANTIFUNGALS
GCN	62498
HICL Sequence Number	007590
HICL Sequence Number Description	TERBINAFINE HCL
Brand/Generic	Generic
Proprietary Name	Walgreens
Proprietary Name Suffix	Athletes Foot
Non-Proprietary Name	Terbinafine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100g
Substance Name	TERBINAFINE HYDROCHLORIDE
Labeler Name	Walgreen Company
Pharmaceutical Class	Allylamine Antifungal [EPC], Allylamine [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA077511
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-2080-02 (00363208002)

Pricing Information	N/A
NDC Package Code	0363-2080-02
Billing NDC	00363208002
Package	1 TUBE in 1 CARTON (0363-2080-02) / 30 g in 1 TUBE
Marketing Start Date	2007-07-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d706c56f-0123-4a5a-8c85-240cbe6ef7a5 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

cures most athlete's foot (tinea pedis)
cures most jock itch (tinea cruris) and ringworm (tinea corporis)
relieves itching, burning, cracking and scaling which accompany these conditions

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 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 for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor. on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor. for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor. wash hands after each use children under 12 years: ask a doctor	1 week between the toes 2 weeks on the bottom or sides of the foot

Other information

do not use if seal on tube is broken or is not visible
store at controlled room temperature 20°-25°C (68°-77°F)
see carton or tube crimp for lot number and expiration date

Inactive ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

WALGREEN CO.

200 WILMOT RD.,

DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

Walgreens

Athlete's Foot Cream

TERBINAFINE HYDROCHLORIDE 1% / ANTIFUNGAL CREAM

NET WT 0.5 OZ (15 g)

Principal Display Panel - 15 g Tube Carton

INGREDIENTS AND APPEARANCE

WALGREENS ATHLETES FOOT

terbinafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-2080
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP)	Terbinafine	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
benzyl alcohol (UNII: LKG8494WBH)
cetyl alcohol (UNII: 936JST6JCN)
cetyl palmitate (UNII: 5ZA2S6B08X)
isopropyl myristate (UNII: 0RE8K4LNJS)
polysorbate 60 (UNII: CAL22UVI4M)
water (UNII: 059QF0KO0R)
sodium hydroxide (UNII: 55X04QC32I)
sorbitan monostearate (UNII: NVZ4I0H58X)
stearyl alcohol (UNII: 2KR89I4H1Y)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-2080-01	1 in 1 CARTON	07/02/2007
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0363-2080-02	1 in 1 CARTON	07/02/2007
2		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	ANDA077511	07/02/2007

Labeler - Walgreen Company (008965063)

Revised: 10/2019

Document Id: d8005a9c-424b-4d89-a6da-a64bfd04cbf5

Set id: d706c56f-0123-4a5a-8c85-240cbe6ef7a5

Version: 3

Effective Time: 20191030

Search by Drug Name or NDC

NDC 00363-2080-02 Walgreens 1 g/100g Details

Walgreens 1 g/100g

Product Information

Package

Package Images

NDC 00363-2080-02 (00363208002)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d706c56f-0123-4a5a-8c85-240cbe6ef7a5 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Do not use

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

INGREDIENTS AND APPEARANCE

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