CLOTRIMAZOLE- clotrimazole cream 
Kinray 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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Antifungal

Purpose


Active Ingredient

Active Ingredient                         Purpose

Clotrimazole 1.0%                      Antifungal

Warnings

Do not use:

Indications & Usage



Other information.

Protect from freezing. Avoid excessive heat.

Dosage & Administration

Inactive Ingredients

Inactive Ingredients: Cetomacrogol 1000, cetostearyl alcohol, liquid paraffin, methylparaben, propylene glycol, propylparaben, purified water, white soft paraffin.

Keep Out of Reach of Children


Principal Display Panel

Kinray Antifungal

KR_Antifungal.jpg

Kinray antifungal

CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63777-231
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
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63777-231-0128.4 g in 1 TUBE; Type 0: Not a Combination Product01/11/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/11/2012
Labeler - Kinray Inc. (012574513)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Blossom Pharmaceuticals677381470manufacture(63777-231)

Revised: 5/2016
Document Id: 6d8ef3b7-2add-44a0-a396-1c5a320518cb
Set id: 93900b18-3327-41a5-b666-e80727407d42
Version: 6
Effective Time: 20160519
 
Kinray Inc.