MICONAZOLE NITRATE - miconazole nitrate cream 
Physicians Total Care, 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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Miconazole Nitrate Antifungal Cream

ACTIVE INGREDIENT

Miconazole nitrate 2%

PURPOSE

Antifungal

USES

WARNINGS

For external use only

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

Do not use on children under 2 years, unless directed by a doctor.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

For athlete’s foot

OTHER INFORMATION

Store at room temperature 59º - 86ºF (15º - 30ºC).

IMPORTANT: The opening of this product is covered by a metal tamper-evident seal. If this seal has been punctured or is not visible, do not use and return product to place of purchase.

TO OPEN: To puncture the seal, reverse the cap and place the puncture-top onto the tube. Push firmly until seal is open. To close, screw the cap back onto the tube.

INACTIVE INGREDIENTS

Benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54868-2471-0

image of package label

Compare to the active ingredient in Micatin® Antifungal Cream*

Actavis

Antifungal Cream

Miconazole Nitrate 2%

Relieves Burning, Cures Most Athlete’s Foot, Jock Itch, Ringworm

Net wt. 14 g  tube cream

07350200D1 VC106266






Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2471(NDC:0472-0735)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
MINERAL OIL (UNII: T5L8T28FGP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-2471-01 in 1 CARTON
114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C03/20/2012
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel(54868-2471)

Revised: 11/2012
Document Id: 52c919c0-4f65-4ed0-9a6d-5fb44d32b39e
Set id: 1ff4dcb5-d4ac-4e4b-a1ae-993f28939942
Version: 2
Effective Time: 20121105
 
Physicians Total Care, Inc.