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

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

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

Directions

Other information

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 description

LEADER CLOTRIMAZOLE ANTI-FUNGAL  
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-760
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-760-101 in 1 CARTON01/11/2016
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/31/2013
Labeler - Cardinal Health (097537435)

Revised: 10/2016
Document Id: cda47ef7-0293-4154-9d2d-5fd2db1f7011
Set id: 5f9337da-ec8a-484d-96f2-01be462edf72
Version: 4
Effective Time: 20161011
 
Cardinal Health