FDA Label for Hi Vetic

View Indications, Usage & Precautions

Hi Vetic Product Label

The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical Co., 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.

Otc - Active Ingredient



Active ingredient    Tolnaftate 1%


Otc - Purpose



Purpose    Antifungal


Indications & Usage



Uses ■for effective treatment of most athlete’s foot, jock itch, and ringworm
          ■prevents the recurrence of most athlete’s foot with daily use


Warnings



Warnings
For external use only


Otc - Do Not Use



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


Otc - When Using



When using this product  ■avoid contact with the eyes


Otc - Stop Use



Stop use and ask a doctor if
■irritation occurs ■there is no improvement within 4 weeks for athlete’s foot and ringworm, and within 2 weeks for jock itch


Otc - Keep Out Of Reach Of Children



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


Dosage & Administration



Directions
■for the treatment of athlete’s foot, jock itch, and ringworm
■cleanse the affected area with soap and water and dry throughly
■apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor
■to prevent athlete’s foot
■cleanse the feet with soap and water and dry throughly
■apply a thin layer of the product to the feet once or twice daily (morning and/or 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 Ingredient



Inactive ingredients  Carboxymethylcellulose sodium, diethyl sebacate, fragrance, glyceryl monostearate, lauromacrogol 400, light mineral oil, polyoxyethylene cetylether, potassium stearate, propylene glycol, simethicone, sodium lauryl sulfate, stearyl alcohol, urea, water, white wax, zinc oxide.


Package Label.Principal Display Panel



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