ANTIFUNGAL CREAM- antifungal cream 
Preferred Pharmaceuticals Inc.

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2% Miconazole Nitrate Cream, USP

Drug Facts

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), Ringworm (tinea corporis).
For the treatment of superficial skin infections caused by yeast (Candida Albicans)
Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet.

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 2 weeks when used for the treatment of jock itch
there is no improvement within 4 weeks when used for athlete's foot and ringworm

Keep out of reach of children

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

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 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 persists longer, consult a doctor.
This product is not effective on scalp or nails.

Other information

Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal.
Store at controlled room temperature.
Preserve in tight container.
See crimp of tube or carton for Lot Number and expiry date.

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

Relabeled By: Preferred Pharmaceuticals Inc.

NDC 68788-8645-2

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

Miconazole Nitrate 2% Cream
ANTIFUNGAL CREAM 
antifungal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8645(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:68788-8645-21 in 1 CARTON05/01/2024
128.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00505/01/2024
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8645)

Revised: 5/2024
Document Id: c6098653-351a-449f-9b1a-0c617074f2b9
Set id: c6098653-351a-449f-9b1a-0c617074f2b9
Version: 1
Effective Time: 20240501
 
Preferred Pharmaceuticals Inc.