Your browser does not support JavaScript! KROGER JOCK ITCH (CLOTRIMAZOLE) CREAM [KROGER COMPANY]
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KROGER JOCK ITCH (clotrimazole) cream
[Kroger Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

  • cures most jock itch (tinea cruris)
  • for effective relief of
    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomfort

Warnings

For external use only

Ask a doctor before use

  • on children under 2 years of age

When using this product

  • avoid contact with eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 2 weeks (for jock itch)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

This product is not effective on the scalp or nails.

For jock itch: use daily for 2 weeks.

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product

Other information

  • To open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 2° - 30°C (36° - 86°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions?

1-800-632-6900

DISTRIBUTED BY
THE KROGER CO.
CINCINNATI, OHIO 45202

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

Kroger®
QUALITY GUARANTEED

Cures Most Jock Itch
JOCK ITCH CREAM

  • Clotrimazole Cream USP,1%
  • Antifungal Cream

NET WT
0.5OZ (15 g)

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
KROGER   JOCK ITCH
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:30142-510
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (Clotrimazole) Clotrimazole10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol 
cetostearyl alcohol 
cetyl esters wax 
octyldodecanol 
polysorbate 60 
water 
sorbitan monostearate 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-510-011 in 1 CARTON
115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C08/31/1993
Labeler - Kroger Company (006999528)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(30142-510)

Revised: 1/2013
 
Kroger Company

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