MICONAZOLE NITRATE- miconazole nitrate cream 
H2-Pharma, LLC

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

Drug Facts

Active ingredient

Miconazole nitrate USP, 2%

Purpose

Antifungal

Uses

Warnings

For external use only

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

When using this product, avoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and 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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Miconazole Nitrate Cream USP, 2%
Antifungal Cream

NDC 61269-735-56
*Compare to the active ingredient in
Micatin® Antifungal Cream

Soothes itching, scaling, cracking, and burning | Cures most athlete's foot, jock itch, and ringworm | Clinically proven

Net wt. 1 oz (28 g)

H2 pharma

Principal Display Panel - 28 g Tube Carton
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61269-735
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)  
APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)  
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61269-735-141 in 1 CARTON06/29/2021
114 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:61269-735-561 in 1 CARTON06/29/2021
228 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:61269-735-421 in 1 CARTON06/29/2021
342.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/29/2021
Labeler - H2-Pharma, LLC (028473634)

Revised: 1/2023
Document Id: ebf2d330-f3ae-47cb-bf87-dbdd0e5c2be8
Set id: 3bfb86ec-55b0-4151-9b74-7243a55dca67
Version: 2
Effective Time: 20230113
 
H2-Pharma, LLC