MICONAZOLE NITRATE- anti fungal micoanzole powder spray aerosol, spray 
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.

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Antifungal Miconazole Powder Spray

Active ingredient

Miconozole nitrate2%

Purpose

Antifungal

Uses

  • cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
  • relieves symtoms of athlete's foot, including itching, burning and cracking

Warnings

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120 o F

When using this product

  • do not get into eyes or mouth
  • use only as directed Intentional misues by deliberatley concentrating and inhaling comtents can be harmful or fatal

Stop use and ask a doctor if

  • irritation occurs
  • no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor ​

Directions

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • 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
  • use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch, if condition persists, consult a doctor
  • this product is not effective on scalp or nails
  • in case of clogging, clear nozzle under running water

Other infomation

Store between 20 o and 30 o C (68 o and 86 o F)

Inactive ingredients

isobutane (propellant), SD alcohol 40-B (14% w/w), stearalkonium hectorite, talc

Questions

Call 1-866-964-0939

PRINCIPAL DISPLAY PANEL

Leader

Medicated

Miconazole Nitrate 2%

Powder Spray

  • Cures Most Jock Itch
  • Relieves Itching, Chafing and Burning

NET WT 4.6 OZ (130g)

Leader Antifungal Miconazole Powder Spray APMSLL-1.jpg

MICONAZOLE NITRATE 
anti fungal micoanzole powder spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-998
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2.6 g  in 130 g
Inactive Ingredients
Ingredient NameStrength
ISOBUTANE (UNII: BXR49TP611)  
ALCOHOL (UNII: 3K9958V90M) 18.2 g  in 130 g
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-998-66130 g in 1 CANISTER; Type 0: Not a Combination Product03/15/201012/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/15/201012/31/2022
Labeler - Cardinal Health Inc. (097537435)

Revised: 10/2020
Document Id: b1a9cee0-30d5-3083-e053-2995a90a4726
Set id: d769f415-4d88-44f6-879f-a3a33793b04c
Version: 4
Effective Time: 20201014
 
Cardinal Health Inc.