TERBINAFINE HYDROCHLORIDE cream

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP)
Available from:
A-S Medication Solutions
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antifungal - 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
Product summary:
Product: 50090-1278 NDC: 50090-1278-0 15 g in a TUBE / 1 in a CARTON
Authorization status:
Abbreviated New Drug Application
Authorization number:
50090-1278-0

TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride cream

A-S Medication Solutions

----------

Terbinafine Hydrochloride

Cream 1%

Antifungal Cream

Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpos e

Antifungal

Us es

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.

side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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.

1 week between the toes

2 weeks on the bottom or

sides of the foot

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.

Distributed by:

Taro Pharmaceuticals U.S.A., Inc.

Hawthorne, NY 10532

HOW SUPPLIED

Product: 50090-1278

NDC: 50090-1278-0 15 g in a TUBE / 1 in a CARTON

Terbinafine Hydrochloride

TERBINAFINE HYDROCHLORIDE

terbinafine hydrochloride cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 0 9 0 -1278 (NDC:516 72-20 8 0 )

A-S Medication Solutions

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TERBINAFINE HYDRO CHLO RIDE (UNII: 0 12C11ZU6 G) (TERBINAFINE -

UNII:G7RIW8 S0 XP)

TERBINAFINE

HYDROCHLORIDE

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

benzyl a lco ho l (UNII: LKG8 49 4WBH)

cetyl a lco ho l (UNII: 9 36 JST6 JCN)

cetyl pa lmita te (UNII: 5ZA2S6 B0 8 X)

iso pro pyl myrista te (UNII: 0 RE8 K4LNJS)

po lyso rba te 6 0 (UNII: CAL22UVI4M)

wa ter (UNII: 0 59 QF0 KO0 R)

so dium hydro xide (UNII: 55X0 4QC32I)

so rbita n mo no stea ra te (UNII: NVZ4I0 H58 X)

stea ryl a lco ho l (UNII: 2KR8 9 I4H1Y)

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 0 9 0 -1278 -0

1 in 1 CARTON

11/28 /20 14

1

15 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 77511

0 7/0 2/20 0 7

Labeler -

A-S Medication Solutions (830016429)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

A-S Medicatio n So lutio ns

8 30 0 16 429

RELABEL(50 0 9 0 -1278 )

Revised: 2/2020

Similar products

Search alerts related to this product

View documents history

Share this information