MICONAZOLE NITRATE- antifungal 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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Antifungal

Drug Facts

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

Treats most jock itch, ringworm and athlete’s foot

Warnings

Do not use

For external use only.

Avoid contact with eyes.

Consult a Doctor

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.

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

If condition persists longer, consult a doctor.

Other Information

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, BHT, Cetyl Alcohol, Dimethicone,
DMDM Hydantoin, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, PEG 100 Stearate,Iodopropynyl Butylcarbamate,

Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine (may contain Citric Acid).

NDC 68599-1471-4

McKesson
Antifungal Cream 2%
MICONAZOLE
NITRATE

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

4 fl oz
(118.3 mL)

MFR # 53-6391

53-6391

MICONAZOLE NITRATE 
antifungal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-1471
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
PEG-100 STEARATE (UNII: YD01N1999R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROLAMINE (UNII: 9O3K93S3TK)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68599-1471-4118 mg in 1 TUBE; Type 0: Not a Combination Product07/25/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/25/2019
Labeler - McKesson (023904428)
Establishment
NameAddressID/FEIBusiness Operations
Central Solutions007118524manufacture(68599-1471)

Revised: 9/2021
Document Id: cbe47117-e4c8-5428-e053-2a95a90a962e
Set id: 8dcca44a-16c7-7262-e053-2a95a90a1b23
Version: 2
Effective Time: 20210913
 
McKesson