OTC Medication Information: Kroger ATHLETES FOOT

KROGER ATHLETES FOOT- clotrimazole cream
Kroger Company

Disclaimer: 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 Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

  • cures most athlete’s foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

For external use only

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot or ringworm) or 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

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete’s foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change socks at least once daily
  • for athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other information

  • To open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20° — 25°C (68° — 77°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 or comments?

1-800-632-6900

DISTRIBUTED BY THE KROGER CO. CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL — 15 g Tube Carton

COMPARE TO the
active ingredient in
LOTRIMIN® AF
*See back panel

NDC 30142-305-01

Kroger®

Athlete’s
Foot Cream

Clotrimazole Cream USP, 1%

ANTIFUNGAL

Cures Most Athlete’s Foot

Relieves Itching, Burning,
Cracking & Scaling

NET WT 0.5 OZ (15 g)

PRINCIPAL DISPLAY PANEL -- 15 g Tube Carton
(click image for full-size original)
KROGER ATHLETES FOOT
clotrimazole cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-305
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Clotrimazole (Clotrimazole) Clotrimazole 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
benzyl alcohol
cetostearyl alcohol
cetyl esters wax
octyldodecanol
polysorbate 60
water
sorbitan monostearate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:30142-305-01 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (30142-305-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333C 08/31/1993
Labeler — Kroger Company (006999528)
Registrant — Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE (30142-305)

Revised: 07/2020 Kroger Company

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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