MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL- miconazole nitrate cream

MICONAZOLE Nitrate 2% Cream ANTIFUNGAL by

Drug Labeling and Warnings

MICONAZOLE Nitrate 2% Cream ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Miconazole Nitrate 2% w/w

Purpose

Anti-Fungal

Uses

• For the treatment and prevention of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis)
• relieves itching, scaling, cracking, burning and discomfort associated with these conditions.

Warnings

For external use only

DO NOT USE

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)

INACTIVE INGREDIENT

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 PANEL

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-041-25	113 g in 1 TUBE; Type 0: Not a Combination Product	08/16/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	03/22/2016

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Establishment
Name	Address	ID/FEI	Business Operations
ASTONEA LABS PRIVATE LIMITED		878533295	manufacture(77338-041)