LEADER MEDICATED- miconazole nitrate powder 
Cardinal Health 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.

----------

Drug Facts

Active ingredient

Miconozole nitrate2%

Purpose

Antifungal

Uses

for the cure of most athlete's foot, jock itch and ringworm

Warnings

For external use only.

Do not use

on children under 2 years of age unless directed by a doctor

When using this product

do not get into eyes.

Stop use and ask a doctor if

if irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.

Keep out of reach of children

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

Directions

Other infomation

Product settles during shipment. Package contains full net weight.

Inactive ingredients

aldioxa, chloroxylenol, fragrance, imidurea, powdered cellulose, talc. Contains no starch

Questions

Call 1-866-964-0939

Box Label

Leader Medicated Miconazole Nitrate 2% PowderLeader Medicated Miconazole Nitrate 2% Powder Spray

LEADER MEDICATED 
miconazole nitrate powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-653
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE 1.42 g  in 71 g
Inactive Ingredients
Ingredient Name Strength
ALDIOXA (UNII: 8T66I31YNK)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
IMIDUREA (UNII: M629807ATL)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-653-18 71 g in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 10/31/2010
Labeler - Cardinal Health Inc. (097537435)

Revised: 10/2012
Document Id: caeacf73-1f2f-48e1-a8c3-0525a46b560b
Set id: 1a809c94-52df-4593-8665-4efd3a20a581
Version: 1
Effective Time: 20121031
 
Cardinal Health Inc.