ANTIFUNGAL- miconazole nitrate powder 
Advanced Rx LLC

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Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

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 and ask a doctor if

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

allantoin, chloroxylenol, corn starch, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate.

Questions?

call toll free 1-800-630-8895

Principal Display Panel

label

ANTIFUNGAL 
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-771
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
ALLANTOIN (UNII: 344S277G0Z)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
STARCH, CORN (UNII: O8232NY3SJ)  
IMIDUREA (UNII: M629807ATL)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80513-771-0385 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00501/01/2025
Labeler - Advanced Rx LLC (042795108)
Registrant - Advanced Rx LLC (042795108)
Establishment
NameAddressID/FEIBusiness Operations
Davion, Inc079536689manufacture(80513-771)

Revised: 7/2025
Document Id: 3af71de6-43f9-b1a2-e063-6394a90a5050
Set id: e13eb653-3916-444a-ae86-1738c0308b79
Version: 1
Effective Time: 20250728
 
Advanced Rx LLC