ANTIFUNGAL- antifungal cream 
Galentic Pharma (India) Priva Te Limited

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 Cream

Active Ingredient

Active Ingredient                       Purpose

Clotrimazole 1.0%                     Antifungal                          

Purpose


Warnings

Do not use:

Indications and Usage

Dosage and Administration

Keep Out Of Reach Of Children

KEEP OUT Of REACH Of CHILDREN

INACTIVE INGREDIENTS

Inactive Ingredients: Cetomicrogol 1000, Cetostearyl alcohol, Liquid paraffin, Methylparaben, Propylene glycol, Propylparaben, Purified water, White soft paraben

Principal Display Panel

Galentic Antifungal Cream

Gal Clotrimazole.jpg

Antifungal

ANTIFUNGAL 
antifungal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-004
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:50382-004-0128.25 g in 1 TUBE
2NDC:50382-004-02113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/07/2013
Labeler - Galentic Pharma (India) Priva Te Limited (918531450)

Revised: 8/2013
Document Id: 64c54ba8-05dd-48a2-b8c3-c26d7f869233
Set id: 7c48c331-adb8-4e9e-b6b9-e633b5188189
Version: 1
Effective Time: 20130807
 
Galentic Pharma (India) Priva Te Limited