LEADER MEDICATED- miconazole nitrate powder

Leader Medicated by

Drug Labeling and Warnings

Leader Medicated by is a Otc medication manufactured, distributed, or labeled by Cardinal Health Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Miconozole nitrate2%

Purpose

Antifungal

INDICATIONS & USAGE

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. ​

Directions

• clean and dry affected area
• 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 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 persists, consult a doctor
• this product is not effective on scalp or nails

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% Powder Spray

INGREDIENTS AND APPEARANCE

LEADER MEDICATED 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-653
Route of Administration	TOPICAL

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)