FDA Label for Relispray Antifungal Liquid

View Indications, Usage & Precautions

Relispray Antifungal Liquid Product Label

The following document was submitted to the FDA by the labeler of this product Midas-care Pharmaceuticals Pvt. Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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.


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



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)


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