Label: RELISPRAY ANTIFUNGAL POWDER- miconazole nitrate aerosol, spray

  • NDC Code(s): 46063-552-12
  • Packager: Midas-Care Pharmaceuticals Pvt. Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

    • effectively treats most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
    • relieves itching, scaling, burning and discomfort which may accompany these conditions
  • 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

    • wash the affected area and dry thoroughly
    • shake can well and apply a thin layer over the affected area twice daily (morning and night)
    • 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
    • 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 longer, consult a doctor
    • this product is not effective on the scalp or nails
  • 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
  • INGREDIENTS AND APPEARANCE
    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 drugM00503/01/2022
    Labeler - Midas-Care Pharmaceuticals Pvt. Ltd. (862273427)
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