relispray antifungal spray powder

relispray antifungal spray powder
SPL v2
SPL
SPL Set ID 93434d3e-6fe4-4fe0-be4f-573d183bf527
Route
topical
Published
Effective Date 2024-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
miconazole (0.02 g)
Inactive Ingredients
aloe vera leaf aluminum starch octenylsuccinate isopropyl myristate liquefied petroleum gas propylene carbonate alcohol sorbitan monooleate stearalkonium hectorite

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-03-01

Purpose

Antifungal

Description

Drug Facts


Medication Information

Warnings

For external use only

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

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
Purpose

Antifungal

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1

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

Active Ingredient

Miconazole nitrate 2%

Questions Or Comments?

Call 888-491-1965

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)
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)


Structured Label Content

Warnings

For external use only

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

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
Purpose

Antifungal

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 (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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

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

Active Ingredient (Active ingredient)

Miconazole nitrate 2%

Questions Or Comments? (Questions or comments?)

Call 888-491-1965

When Using This Product (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 (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)
Principal Display Panel 128 G Can Label (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)


Advanced Ingredient Data


Raw Label Data

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