ANTIFUNGAL- miconazole nitrate cream 
McKesson

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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McKesson Antifungal Cream

Drug Facts

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

Treats most jock itch, ringworm and athlete’s foot

WarningsDo not use

Avoid contact with eyes.

If irritation occurs or if there is no improvement within 4
weeks for athlete’s foot or ringworm, or within 2 weeks
for jock itch, discontinue use and consult a doctor.

Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.

Directions

Athlete’s foot

Athlete’s foot and ringworm

Jock Itch

This product is not effective on scalp or nails.

Other information Store at 59-86ºF (15-30ºC).

Inactive ingredients Purified Water, Isopropyl Palmitate, Glycerin, Glyceryl Stearate, PEG 100 Stearate, Cetearyl Alcohol,
Cyclopentasiloxane, Propylene Glycol, Polyquaternium-37, Dicaprylate/Dicaprate, PPG-1 Trideceth-6, Aloe Barbadensis Leaf
Juice, DMDM Hydantoin, Iodopropynyl Butylcarbamate, (may contain Lactic Acid).

Questions? Call 1-800-777-4908

McKesson

Antifungal Cream

2% Miconazole Nitrate

Relieves itching, cracking, scaling and discomfort associated with most jock itch, ringworm and athlete’s foot.

Net Contents

4 fl oz

(118.3mL)

MFR# 53-6391

53-6391 each

ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-1470
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)  
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
ALOE (UNII: V5VD430YW9)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
GLYCINE (UNII: TE7660XO1C)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68599-1470-4118 mL in 1 TUBE; Type 0: Not a Combination Product05/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/26/2017
Labeler - McKesson (023904428)
Establishment
NameAddressID/FEIBusiness Operations
Central Solutions007118524manufacture(68599-1470)

Revised: 10/2017
Document Id: 5beb0a51-deaf-6e53-e053-2991aa0adbde
Set id: 5021a45b-5c85-0ef8-e054-00144ff8d46c
Version: 2
Effective Time: 20171019
 
McKesson