RELISPRAY ANTIFUNGAL POWDER- miconazole nitrate aerosol, spray 
Midas-Care Pharmaceuticals Pvt. Ltd.

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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Relispray Antifungal Spray Powder

Drug Facts

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

Warnings

For external use only

Flammable. Do not use while smoking or near heat or flame.

Do not use on children under 2 years of age unless directed by a doctor

When using this product

  • avoid contact with the eyes
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal
  • do not puncture or incinerate. Contents under pressure.
    Do not store at temperatures above 120°F

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 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

Inactive ingredients

aloe vera, aluminum starch octenyl succinate, isopropyl myristate, propellant (isobutane, normal butane, propane), propylene carbonate, SD alcohol 40-B (10% w/w), sorbitan monooleate, stearalkonium hectorite

Questions or comments?

Call 888-491-1965

PRINCIPAL DISPLAY PANEL - 128 g Can Label

NDC 46063-552-12

Relispray
Antifungal
Spray
Powder

Miconazole Nitrate
2% Antifungal
Spray Powder

Net Wt 4.5 oz (128g)

PRINCIPAL DISPLAY PANEL - 128 g Can Label
RELISPRAY ANTIFUNGAL POWDER 
miconazole nitrate aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46063-552
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) Miconazole Nitrate0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V)  
Propylene carbonate (UNII: 8D08K3S51E)  
ALCOHOL (UNII: 3K9958V90M)  
Sorbitan monooleate (UNII: 06XEA2VD56)  
Stearalkonium hectorite (UNII: OLX698AH5P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46063-552-12128 g in 1 CAN; Type 0: Not a Combination Product03/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/01/2022
Labeler - Midas-Care Pharmaceuticals Pvt. Ltd. (862273427)

Revised: 1/2022
Document Id: 692ad959-7088-4fe5-9ff7-66b1e26f517f
Set id: 93434d3e-6fe4-4fe0-be4f-573d183bf527
Version: 1
Effective Time: 20220128
 
Midas-Care Pharmaceuticals Pvt. Ltd.