ANTIFUNGAL- miconazole nitrate cream 
A-S Medication Solutions

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 Cream, USP

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 right away.

Directions

Other information

Inactive ingredients

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

Questions?

 1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

HOW SUPPLIED

Product: 50090-2231

NDC: 50090-2231-0 14 g in a TUBE / 1 in a CARTON

miconazole nitrate

Label Image
ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-2231(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)  
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-2231-01 in 1 CARTON11/16/2015
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C06/01/1997
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-2231)

Revised: 2/2021
Document Id: da6efa5a-89cc-4999-8991-ea2a35f7b8f5
Set id: c3637989-42e9-479b-a343-d661f9b104a9
Version: 10
Effective Time: 20210205
 
A-S Medication Solutions