ANTIFUNGAL- 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 Cream, USP

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 right away.

Directions

•
wash 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 lasts longer, contact a doctor
•
this product is not effective on the scalp or nails

Other information

•
store at controlled room temperature 59°-86°F (15°-30°C).
•
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?

 1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

Principal Display Panel

Actavis
NDC 68788-7374-2
Compare to the active ingredient in Micatin® Antifungal Cream*  

Antifungal Cream
Miconazole Nitrate Cream, USP 2%
Soothes Itching, Scaling, Cracking, and Burning 

Cures Most Athlete’s Foot, Jock Itch & Ringworm 

Net wt. 0.5 oz (14g)

Relabeled By: Preferred Pharmaceuticals Inc.

Miconazole Nitrate 2% Cream
ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7374(NDC:0472-0735)
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)  
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-7374-21 in 1 CARTON08/25/201611/29/2022
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 finalpart333C08/25/201611/29/2022
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7374)

Revised: 9/2022
Document Id: 191c06c4-789f-4e89-86e4-015145618a34
Set id: d87085da-7c3d-4837-b526-37b7fd95b9c0
Version: 8
Effective Time: 20220912
 
Preferred Pharmaceuticals Inc.