ATHLETES FOOT TMICONAZOLE NITRATE- 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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Athlete's Foot Liquid TMiconazole Nitrate

Drug Facts

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

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

Warnings

For external use only.

Extremely flammable: Contents under pressure. Keep away from fire, sparks, and heated surfaces. Do not puncture or incinerate container. Exposure to temperatures above 120°F  may cause bursting. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful of fatal.

Do not use

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

When using this product

  • avoid contact with the eyes or mouth
  • use only as directed

Stop use and ask a doctor if

  • irritation occurs
  • no improvement within 4 weeks for athlete's foot and ringworm, and 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

  • 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
  • for athlete's foot: pay special attention to spaces between the 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 the scalp or nails

Other information

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

Inactive ingredients

acetone, ethoxydiglycol, propylene glycol, SD alcohol 40-B (74% w/w), tocopheryl acetate

Questions?

Call 1-866-964-0939

Package Labeling:

Label2

ATHLETES FOOT TMICONAZOLE NITRATE 
miconazole nitrate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68754-205
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
ACETONE (UNII: 1364PS73AF)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68754-205-00150 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: 6157820d-4617-ea51-e053-2991aa0a847b
Set id: bd3a5e7f-e3f5-4e6c-8be8-f226729f3ec6
Version: 1
Effective Time: 20171227
 
American Spraytech, LLC