MICONAZOLE NITRATE- anti-fungal miconazole athletes foot spray talc free aerosol, powder 
Foodhold USA

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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CareOne Miconazole Antifungal Athlete's Foot Powder Spray Talc-Free

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

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 120ºF. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

When using this product

  • do not get into 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

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

Other information

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

Inactive ingredients

SD alcohol 40-B(10%w/w), isobutane (propellant), stearalkonium hectorite, talc

Questions?

call 1-866-964-0939

Principal Display Panel

CareOne

ANTIFUNGAL

ATHLETE'S FOOT

POWDER SPRAY

MICONAZOLE NITRATE 2%

CURES MOST ATHLETE'S FOOT

RELIEVES ITCHING, CRACKING, AND BURNING

TALC- FREE

NET WT 4.6 (130 g)

Care One_Antifungal Miconazole AF Powder Spray_50-031CO-01-01.jpg

MICONAZOLE NITRATE 
anti-fungal miconazole athletes foot spray talc free aerosol, powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-565
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
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISOBUTANE (UNII: BXR49TP611)  
KAOLIN (UNII: 24H4NWX5CO)  
ALCOHOL (UNII: 3K9958V90M)  
ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-565-46130 g in 1 CAN; Type 0: Not a Combination Product10/20/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/20/2017
Labeler - Foodhold USA (809183973)

Revised: 12/2019
Document Id: 98cf51a1-6dd7-d653-e053-2995a90abc2e
Set id: a64c9371-0ac7-4c47-bc12-7bc77162b244
Version: 2
Effective Time: 20191203
 
Foodhold USA