ANTIFUNGAL CREAM- antifungal cream 
BluePoint Laboratories

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2% Miconazole Nitrate Cream, USP

Drug Facts

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Centre right away.

Directions

Other information

Inactive ingredients

Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether 20, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium Phosphate Monobasic Dihydrate, White Petrolatum.

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram and Company Limited.

Plot No. A327, T.T.C. Indl. Area, M.I.D.C.

Mahape, Navi Mumbai - 400710 Mfg. Lic. No.: KD/739

For BluePoint Laboratories

2% Miconazole Nitrate Cream, USP Carton 1oz (28.4g)

carton

2% Miconazole Nitrate Cream, USP Tube 1oz (28.4g)

1 oz tube

2% Miconazole Nitrate Cream, USP Carton 0.5oz (14.2g)

0.5 carton

2% Miconazole Nitrate Cream, USP Tube 0.5oz (14.2g)

0.5 tube

2% Miconazole Nitrate Cream, USP Carton 1.5oz (42.5g)

1.5 carton

2% Miconazole Nitrate Cream, USP Tube 1.5oz (42.5g)

1.5 tube

ANTIFUNGAL CREAM 
antifungal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-481
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
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
CHLOROCRESOL (UNII: 36W53O7109)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68001-481-451 in 1 CARTON12/01/2020
128.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:68001-481-471 in 1 CARTON12/01/2020
242.5 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:68001-481-481 in 1 CARTON12/01/2020
314.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00512/01/2020
Labeler - BluePoint Laboratories (985523874)
Establishment
NameAddressID/FEIBusiness Operations
Gopaldas Visram & Co., Ltd858030888manufacture(68001-481)

Revised: 11/2023
Document Id: 097d4e93-7f8b-53f8-e063-6294a90a4e40
Set id: b564f971-2a9b-a605-e053-2995a90aee69
Version: 3
Effective Time: 20231117
 
BluePoint Laboratories