BUDPAK ANTIFUNGAL MICONAZOLE NITRATE- miconazole nitrate 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.

----------

Budpak Antifungal Miconazole Nitrate Cream

Active Ingredient

Miconazole Nitrate 2.0%

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

Benzoic Acid, Butylated Hydroxy Anisole, Mineral Oil, PEGlicol-5-Oleate, Pegoxol-7 Stearate, Purified Water.

PRINCIPAL DISPLAY PANEL

Budpak Antifungal Cream

Miconazole Nitrate 2%

Antifungal for Athlete’s Foot and Jock Itch

NET WT 0.5 OZ (14 g)

image of package label

BUDPAK ANTIFUNGAL MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
MINERAL OIL (UNII: T5L8T28FGP)  
PEG-5 OLEATE (UNII: 0240V77G50)  
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27293-023-011 in 1 BOX
1NDC:27293-023-1414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/29/2013
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-023)

Revised: 11/2013
Document Id: 37440f2f-0bc8-4799-8a1e-514b8d86a388
Set id: 1a156ca6-b290-4ab8-9efa-1ceebeabf7c2
Version: 1
Effective Time: 20131129
 
Budpak Inc.