BUDPAK ANTIFUNGAL CLOTRIMAZOLE- clotrimazole cream 
Budpak 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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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 eyes.

Stop using this product and ask a doctor

Keep this and all drugs out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Purified Water, Mineral Oil, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Propylene Glycol, Polysorbate 60, Sorbitan mono stearate, Methylparaben, Propylparaben.

PRINCIPAL DISPLAY PANEL

Budpak Antifungal Cream

Clotrimazole 1%

NET WT 0.5 OZ (14 g)

image of package label

BUDPAK ANTIFUNGAL CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27293-025-011 in 1 BOX
1NDC:27293-025-1414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/17/2012
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-025)

Revised: 11/2012
Document Id: 4917ddf3-ebec-4149-b6d7-9fd4d59268b3
Set id: 0acfb654-fa70-4887-a67c-dfbe950f431a
Version: 1
Effective Time: 20121120
 
Budpak Inc.