MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL- miconazole nitrate cream 
ASTONEA LABS PRIVATE LIMITED

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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:77338-041
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:77338-041-25113 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 DrugM00503/22/2016
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
Establishment
NameAddressID/FEIBusiness Operations
ASTONEA LABS PRIVATE LIMITED878533295manufacture(77338-041)

Revised: 6/2024
Document Id: 1bbb26c7-7122-8c78-e063-6394a90ae6a6
Set id: e66191a6-0c3c-7319-e053-2a95a90aae84
Version: 2
Effective Time: 20240625
 
ASTONEA LABS PRIVATE LIMITED