KROGER ANTIFUNGAL- terbinafine hydrochloride cream

Kroger by

Drug Labeling and Warnings

Kroger by is a Otc medication manufactured, distributed, or labeled by Kroger Company, Taro Pharmaceuticals U.S. A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 or comments?

1-800-632-6900

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DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

Kroger®
FROM OUR FAMILY
TO YOURS

athlete's foot cream
TERBINAFINE HYDROCHLORIDE CREAM 1%
ANTIFUNGAL CREAM

NET WT 0.5 OZ (15 g)

INGREDIENTS AND APPEARANCE

KROGER   ANTIFUNGAL
terbinafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-080
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-080-01	1 in 1 CARTON
1		15 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077511	07/02/2007

Labeler - Kroger Company (006999528)

Registrant - Taro Pharmaceuticals U.S. A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(30142-080)