Miconazole Nitrate Cream, USP

Antifungal by

Drug Labeling and Warnings

Antifungal by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

  • proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
  • for effective relief of itching, scaling, cracking, burning, and discomfort

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

  • wash the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition lasts longer, contact a doctor
  • this product is not effective on the scalp or nails

Other information

  • store at controlled room temperature 59°-86°F (15°-30°C).
  • before using any medication, read all label directions. Keep carton, it contains important 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

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 CARTON11/16/201510/31/2019
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 FINALpart333C06/01/199710/31/2019
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-2231)

Revised: 1/2020
Document Id: fd8317a0-f3b6-45bc-944a-11cfa85502e9
Set id: c3637989-42e9-479b-a343-d661f9b104a9
Version: 8
Effective Time: 20200118
 
A-S Medication Solutions