MICONAZOLE NITRATE- miconazole nitrate cream 
Aru Pharma 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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QPACK MICONAZOLE NITRATE CREAM 2%

Drug Facts

Active ingredient

Miconazole Nitrate USP 2%

Purpose

Antifungal

Uses

Warnings

For external use only
Do not use on children less than 2 years of age unless directed by a doctor
When using this product avoid contact with eyes
Stop use and ask a doctor if • irritation occurs • condition persist • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Inactive ingredients

Cetostearyl alcohol, Cetomacrogol 1000, Paraffin wax, Micro crystalline wax, Light liquid paraffin, Polyethylene Glycol, Chlorocresol and purified water

Other information

• Do not use if seal is damaged or is not visible. • To open, unscrew cap, pull tab to remove foil seal • store at room temperature not exceeding 30​°​C (86​°​F). Do not freeze. • see carton or tube crimp for lot number and expiration date

Questions or comments?

1 844 500-2729‬ between 9 am and 4 pm EST, Monday to Friday.

CURES MOST ATHLETE'S FOOT

Relieves Itching and Burning Sensation Relieves from Cracking and scaling. Grease less and non-staining

Compared to the active ingredient in Micatin

Distributed by.

ARU PHARMA INC.
MOUNT VERNON, NY 10552

www.qpackrx.com

Packaging

Micnzle1

MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70403-924
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
CHLOROCRESOL (UNII: 36W53O7109)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (white to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70403-924-301 in 1 CARTON01/01/201803/31/2025
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/201803/31/2025
Labeler - Aru Pharma Inc. (079736192)

Revised: 5/2023
Document Id: cb0873b4-3fda-4b20-8f61-bc86c04f5f2c
Set id: 0eecb20d-49bc-4186-ac29-f839536b5de2
Version: 4
Effective Time: 20230515
 
Aru Pharma Inc.