KROGER  ANTIFUNGAL- terbinafine hydrochloride cream 
Kroger Company

----------

Kroger®
Antifungal

Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

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

  • 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
Figure

Other information

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

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)

Principal Display Panel - 15 g Tube Carton
KROGER   ANTIFUNGAL
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:30142-080
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Terbinafine Hydrochloride (Terbinafine) Terbinafine1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol 
cetyl alcohol 
cetyl palmitate 
isopropyl myristate 
polysorbate 60 
water 
sodium hydroxide 
sorbitan monostearate 
stearyl alcohol 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-080-011 in 1 CARTON
115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751107/02/2007
Labeler - Kroger Company (006999528)
Registrant - Taro Pharmaceuticals U.S. A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(30142-080)

Revised: 6/2013
Document Id: dc1c99c4-3f5b-4a8c-91b1-d5ab56cb0d1c
Set id: 32e79416-5de4-4f06-9fff-f8c36a1ad5db
Version: 2
Effective Time: 20130627
 
Kroger Company