MICONAZOLE NITRATE- miconazole nitrate cream 
Preferred Pharmaceuticals Inc.

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

Drug Facts

Active ingredient

Miconazole nitrate USP, 2%

Purpose

Antifungal

Uses

proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
for effective relief of itching, scaling, cracking, burning, and discomfort

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 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 the 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 lasts longer, contact a doctor
this product is not effective on the scalp or nails

Other information

do not use if foil seal on tube opening is broken or missing
to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
store at room temperature 15°-30°C (59°-86°F)
before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Miconazole Nitrate Cream USP, 2%
Antifungal Cream

NDC 68788-8107-2
*Compare to the active ingredient in
Micatin® Antifungal Cream

Soothes itching, scaling, cracking, and burning | Cures most athlete's foot, jock itch, and ringworm | Clinically proven

Net wt. 1 oz (28 g)

H2 pharma

Relabeled By: Preferred Pharmaceuticals Inc.

Miconazole Nitrate 2% Cream
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8107(NDC:61269-735)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
MINERAL OIL (UNII: T5L8T28FGP)  
APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)  
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-8107-21 in 1 CARTON11/03/2021
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/03/2021
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8107)

Revised: 8/2023
Document Id: e76d58ca-e436-4e3a-b429-95486caf5423
Set id: 865f499a-0480-44dc-8b6d-6331078ea0f4
Version: 3
Effective Time: 20230807
 
Preferred Pharmaceuticals Inc.