Label: RELISPRAY ANTIFUNGAL LIQUID- tolnaftate aerosol, spray

  • NDC Code(s): 46063-810-12
  • Packager: Midas-Care Pharmaceuticals Pvt. Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 28, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • 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

    Butylated hydroxytoluene, fragrance, polyethylene glycol 400, propellant (isobutane, normal butane, propane), SD alcohol 40-B (41% w/w)

  • Questions or comments?

    Call 888-491-1965

  • PRINCIPAL DISPLAY PANEL - 128 g Can Label

    NDC 46063-810-12

    Relispray
    Antifungal
    Spray
    Liquid

    Tolnaftate 1%
    Antifungal Spray
    Liquid

    Net Wt 4.5 oz (128g)

    PRINCIPAL DISPLAY PANEL - 128 g Can Label
  • INGREDIENTS AND APPEARANCE
    RELISPRAY ANTIFUNGAL LIQUID 
    tolnaftate aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46063-810
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    Polyethylene glycol 400 (UNII: B697894SGQ)  
    LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46063-810-12128 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)
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