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NDC 63187-0111-15 Terbinafine Hydrochloride 1 g/100g Details

Terbinafine Hydrochloride 1 g/100g

Terbinafine Hydrochloride is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is TERBINAFINE HYDROCHLORIDE.

Product Information

NDC	63187-0111
Product ID	63187-111_96ea8a54-d84e-4ac6-9ce1-2624f20a4992
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	Terbinafine Hydrochloride
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	Proficient Rx LP
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 63187-0111-15 (63187011115)

Pricing Information	N/A
NDC Package Code	63187-111-15
Billing NDC	63187011115
Package	1 TUBE in 1 CARTON (63187-111-15) / 15 g in 1 TUBE
Marketing Start Date	2018-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 76f7525d-2005-4da8-a795-50ede6236c68 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.
•: 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. • 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.

SPL UNCLASSIFIED SECTION

Distributed by:

Taro Pharmaceuticals U.S.A., Inc.

Hawthorne, NY 10532

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL - 30 g Carton

Cures Most Athlete's Foot

Terbinafine Hydrochloride

Cream 1%

Antifungal Cream

Full Prescription Strength

NET WT 1 oz (30 g)

INGREDIENTS AND APPEARANCE

TERBINAFINE HYDROCHLORIDE

terbinafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-111(NDC:51672-2080)
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:63187-111-15	1 in 1 CARTON	12/01/2018
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:63187-111-30	1 in 1 CARTON	12/01/2018
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 - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-111) , RELABEL(63187-111)

Revised: 7/2022

Document Id: 96ea8a54-d84e-4ac6-9ce1-2624f20a4992

Set id: 76f7525d-2005-4da8-a795-50ede6236c68

Version: 6

Effective Time: 20220701

Search by Drug Name or NDC

NDC 63187-0111-15 Terbinafine Hydrochloride 1 g/100g Details

Terbinafine Hydrochloride 1 g/100g

Product Information

Package

Package Images

NDC 63187-0111-15 (63187011115)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 76f7525d-2005-4da8-a795-50ede6236c68 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Do not use

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 30 g Carton

INGREDIENTS AND APPEARANCE

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