MICONOLE- miconazole nitrate cream 
Option Labs

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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Miconole

Drug Facts

Miconazole Nitrate 2%

Aloe Vera Polysaccharide 1%

Purpose

Antifungal

Other ingredients:

Allantoin, Cetyl Alcohol, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water, Sodium Hydroxide, Stearic Acid, Fragrance

Uses

for the treatment of

Warnings

for external use only

  • do not use on children under 2 years of age unless directed by a doctor
  • avoid contact with eyes
  • If irritation occurs or if there is no improvement within 2 weeks, discontinue use and see a doctor

Keep out of reach of children.

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

Directions

Other Information

Store at 20°C - 25°C (68°F - 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).  See USP Controlled Room Temperature.

Comments

You may report side effects to FDA at 1-800-FDA-1088

PRINCIPAL DISPLAY PANEL

Miconole Label

NDC 43645-112-45

Manufactured for:

Option Labs.

801 Noble St., 8th Floor Commerce Tower

Anniston, AL 36201

Miconole

(miconazole nitrate 2%) Cream

with Aloe Vera (proprietary patented

polysaccharides from heart of aloe)

Net Wt. 1.5 oz.

Rev. 02/13

MICONOLE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43645-112
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALLANTOIN (UNII: 344S277G0Z)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43645-112-451 in 1 CARTON
142.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/15/2013
Labeler - Option Labs (078380329)
Registrant - Option Labs (078380329)

Revised: 8/2013
Document Id: 6c90e09c-fb30-4508-87a2-c55d3a670d1d
Set id: 52057f7d-377e-4dd9-809e-fcdb8c214998
Version: 1
Effective Time: 20130815
 
Option Labs