CLOTRIMAZOLE - clotrimazole cream 
LIFElabs, a Division of Atico International USA, INC.

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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LIFElabs, a Division of Atico International USA, INC.

Clotrimazole

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

Warnings

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

For external use only.

When using this product avoid contact with the eyes.

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

store between 2o and 30o C (30o and 86o F) Lot No. and Exp. Date: see box or see crimp of tube

Inactive ingredients

benzyl alcohol, isopropyl myristate, liquid parafin, polysorbate 60, propylene glycol, purified water, stearic acid, stearyl aclohol, sorbitan monostearate

Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

mage of Clotrimazole Antifungal Cream Carton Label

mage of Clotrimazole Antifungal Cream Tube Label



CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51852-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Benzyl Alcohol (UNII: LKG8494WBH)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Mineral Oil (UNII: T5L8T28FGP)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Sorbitan Monostearate (UNII: NVZ4I0H58X)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51852-103-011 in 1 BOX
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/01/2010
Labeler - LIFElabs, a Division of Atico International USA, INC. (073876450)

Revised: 8/2010
Document Id: a523aa80-9557-40c6-b522-00471cdf364c
Set id: bca482ac-4b65-450e-bc27-c50af9cd0416
Version: 6
Effective Time: 20100823
 
LIFElabs, a Division of Atico International USA, INC.