LEADER CLOTRIMAZOLE ANTI-FUNGAL  - clotrimazole cream 
Cardinal Health

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.

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Active ingredient                                                                    Purpose

Clotrimazole 1%..................................................................Antifungal

Uses

  • cures most athletes foot, jock itch, and ringworms
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings For external use only.

When using this product avoid contact with the eyes

Do not use on children under 2 years of age except under the advice and supervision of a doctor

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and 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) or as directed by a doctor
  • 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 shoes and socks at least once a day
  • for athlete's foot and ringworm use daily
  • this product is not effective on the scalp or nails

Other information

  • Store between 20°C and 25°C (68°F and 77°F)
  • Lot No. and Exp. Date: see box or see crimp of tube

Inactive ingredients benzyl alcohol, isopropyl myristate, liquid paraffin, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearic acid, stearyl alcohol

Distributed By Cardinal Health

Dublin, Ohio 73017

Made in Korea

image of carton label

LEADER CLOTRIMAZOLE ANTI-FUNGAL  
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-760
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
ISOPROPYL MYRISTATE 
MINERAL OIL 
POLYSORBATE 60 
PROPYLENE GLYCOL 
WATER 
SORBITAN MONOSTEARATE 
STEARIC ACID 
STEARYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:37205-760-101 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/31/2013
Labeler - Cardinal Health (097537435)

Revised: 05/2013
 
Cardinal Health