Relispray Antifungal Powder
FDA Label NDC 46063-552

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Midas-care Pharmaceuticals Pvt. Ltd. for the product Relispray Antifungal Powder (NDC 46063-552). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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.

Otc - Do Not Use

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)

Otc - Keep Out Of Reach Of Children

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)

Principal Display Panel (128 g Can Label)

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