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NDC 36800-0080-01 Athletes Foot 1 g/100g Details

Athletes Foot 1 g/100g

Athletes Foot is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is TERBINAFINE HYDROCHLORIDE.

Product Information

NDC	36800-0080
Product ID	36800-080_a7a50c80-4e9a-41b0-ab6d-44c03ed2449d
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	Athletes Foot
Proprietary Name Suffix	n/a
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	Topco Associates LLC
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 36800-0080-01 (36800008001)

Pricing Information	N/A
NDC Package Code	36800-080-01
Billing NDC	36800008001
Package	1 TUBE in 1 CARTON (36800-080-01) / 15 g in 1 TUBE
Marketing Start Date	2007-07-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5019361d-e6af-4c3d-a246-a43358ae914c 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 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 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 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° to 25°C (68° to 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 1-888-423-0139

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

TopCare®

health™

FULL PRESCRIPTION STRENGTH

Athlete's Foot Cream

TERBINAFINE HYDROCHLORIDE CREAM 1% • ANTIFUNGAL

• OUR PHARMACISTS

RECOMMEND •

NET WT 0.5 OZ (15 g)

Principal Display Panel - 15 g Tube Carton

INGREDIENTS AND APPEARANCE

ATHLETES FOOT

terbinafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-080
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP)	Terbinafine Hydrochloride	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:36800-080-01	1 in 1 CARTON	07/02/2007
1		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
ANDA	ANDA077511	07/02/2007

Labeler - Topco Associates LLC (006935977)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(36800-080)

Revised: 3/2019

Document Id: a7a50c80-4e9a-41b0-ab6d-44c03ed2449d

Set id: 5019361d-e6af-4c3d-a246-a43358ae914c

Version: 2

Effective Time: 20190308

Search by Drug Name or NDC

NDC 36800-0080-01 Athletes Foot 1 g/100g Details

Athletes Foot 1 g/100g

Product Information

Package

Package Images

NDC 36800-0080-01 (36800008001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 5019361d-e6af-4c3d-a246-a43358ae914c 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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