MICONAZOLE NITRATE- antifungal miconazole powder spray aerosol, spray 
Premier Brands of America 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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Soothing Feet Antifungal Miconazole Powder Spray

Active ingredient

Miconozole nitrate 2%

Purpose

Antifungal

Uses

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°F. Intentional misuse by deliberately concentrationg and inhaling contents can be harmful or fatal.

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; 2 weeks for jock itch

Do not use

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

Keep out of reach of children

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

Directions

Other infomation

store between 20 o and 30 o C (68 o and 86 oF)

Inactive ingredients

disteardimonium hectorite, isobutane, kaolin, SD alcohol 40-B, zea mays (corn) starch

Questions

Call 1-866-964-0939

PRINCIPAL DISPLAY PANEL

Foot Powder Spray

Miconazole Nitrate 2%/

ANTIFUNGAL

Cures Most Athelete's Foot

Relieves Itching, Cracking and Burning

Talc Free

NET WT 4.6 OZ (130g)

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MICONAZOLE NITRATE 
antifungal miconazole powder spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-121
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)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)  
KAOLIN (UNII: 24H4NWX5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56104-121-01130 g in 1 CANISTER; Type 0: Not a Combination Product04/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/12/2022
Labeler - Premier Brands of America Inc. (117557458)

Revised: 4/2022
Document Id: ddcbbaae-ca22-9e18-e053-2a95a90a267f
Set id: dc7a23bb-b246-89b1-e053-2995a90a9f2d
Version: 3
Effective Time: 20220429
 
Premier Brands of America Inc.