JOCK ITCH MICONAZOLE NITRATE ANTIFUNGAL- miconazole nitrate spray 
American Spraytech, LLC

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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Jock Itch Powder Spray Miconazole Nitrate 2 Antifungal

Drug Facts

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

  • cures most jock itch (tinea cruris
  • relieves symptoms of jock itch including itching, burning and chafing associated with jock itach

Warnings

For external use only.

Flammable: Do not ues while smoking or near heat or flame. Do not punture or incinerate. Contents under pressure. Do not store at temperature above 120°F.

When using this product

  • do not get into eyes or mouth
  • use only as directed intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Stop use and ask a doctor if

  • irritation occurs
  • no improvement within 2 weeks

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) or as directed by a doctor
  • supervise children in the use of this product
  • use daily for 2 weeks; if condition persists, consult a doctor
  • in case of clogging, clear nozzle under water
  • this product is not effective on scalp or nails

Other information

  • store between 20° and 30°C (68° and 86°F)

Inactive ingredients

isobutane (propellant) SD Alcohol 40-B (14% w/w), Stearalkonium Hectorite, talc

Questions?

1-888-287-1915

Package Labeling:

Label3

JOCK ITCH MICONAZOLE NITRATE ANTIFUNGAL 
miconazole nitrate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68754-207
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
ISOBUTANE (UNII: BXR49TP611)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68754-207-00130 g in 1 BOX; Type 0: Not a Combination Product12/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/26/2017
Labeler - American Spraytech, LLC (137135237)

Revised: 12/2017
Document Id: 6157875b-d992-f0e5-e053-2991aa0a1217
Set id: fd148b34-5bb4-4f6b-92cc-c8cfb5b30405
Version: 1
Effective Time: 20171227
 
American Spraytech, LLC