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NDC 11822-0080-02 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 Rite Aid Corporation. The primary component is TERBINAFINE HYDROCHLORIDE.

Product Information

NDC	11822-0080
Product ID	11822-0080_91eb290c-78f1-4a2c-be0d-c7229ebc1bb5
Associated GPIs	90150087103710
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	Rite Aid Corporation
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 11822-0080-02 (11822008002)

Pricing Information	N/A
NDC Package Code	11822-0080-2
Billing NDC	11822008002
Package	1 TUBE in 1 CARTON (11822-0080-2) / 30 g in 1 TUBE
Marketing Start Date	2019-10-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a7b0a70b-a117-48cf-a6bc-260be1dac1e7 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 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

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:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

Athlete's Foot Cream

Terbinafine Hydrochloride Cream 1%

ANTIFUNGAL

RITE

AID®

PHARMACY

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:11822-0080
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:11822-0080-1	1 in 1 CARTON	10/28/2019
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11822-0080-2	1 in 1 CARTON	10/28/2019
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 - Rite Aid Corporation (014578892)

Revised: 11/2019

Document Id: 91eb290c-78f1-4a2c-be0d-c7229ebc1bb5

Set id: a7b0a70b-a117-48cf-a6bc-260be1dac1e7

Version: 2

Effective Time: 20191111

Search by Drug Name or NDC

NDC 11822-0080-02 Athletes Foot 1 g/100g Details

Athletes Foot 1 g/100g

Product Information

Package

Package Images

NDC 11822-0080-02 (11822008002)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a7b0a70b-a117-48cf-a6bc-260be1dac1e7 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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