MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL- miconazole nitrate cream 
GERI-GENTLE CORPORATION

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 2% Cream ANTIFUNGAL

Drug Facts

Active ingredient

Miconazole Nitrate 2% w/w

Purpose

Anti-Fungal

Uses

Warnings

For external use only

on children under 2 years of age unless directed by Doctor

When using this product

Avoid contact with eyes

Stop use and ask a doctor if

irritation occurs

there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

Keep out of reach of children

In case of accidental ingestion contact a physician or Poison Control Center right away and discomfort which accompany these conditions

Directions

Clean 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 healthcare professional • Supervise children in the use of this product.

For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks atleast once daily.

For ringworm: Use daily for 4 weeks. If condition persists, consult a healthcare professional.

For jock itch: Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.

This product is not effective on the scalp or nails.

Other Information

• Store at 15° - 30° c (59° - 86° f)

Caprylic/capric triglyceride, Cetereath-20, Cetearyl Alcohol, Chlorocresol, Dimethicone, Disodium EDTA, Glyceryl Stearate, Imidazolidinyl Urea, PEG-100 Stearate, PEG-40 Castor Oil, Petrolatum, Propylene Glycol, Sodium Cetearyl Sulfate, Stearic Acid, Water, Xanthum Gum

Principal Display and Drug Fact Panel

MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69771-041
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PEG-100 STEARATE (UNII: YD01N1999R)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CHLOROCRESOL (UNII: 36W53O7109)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
IMIDUREA (UNII: M629807ATL)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
PETROLATUM (UNII: 4T6H12BN9U)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69771-041-25113 g in 1 TUBE; Type 0: Not a Combination Product08/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/22/2016
Labeler - GERI-GENTLE CORPORATION (080367686)

Revised: 8/2022
Document Id: e6734948-06c0-f059-e053-2995a90a3962
Set id: e6734616-c16b-430c-e053-2a95a90a18f8
Version: 1
Effective Time: 20220817
 
GERI-GENTLE CORPORATION