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Hi Vetic

Sato Pharmaceutical Co., Ltd.

DRUG FACTS




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredient    Tolnaftate 1%

Purpose

Purpose    Antifungal

Uses

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
For external use only

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

When using this product  ■avoid contact with the eyes

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

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

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 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.

hiveticointPDP.jpgHi Vetic

hiveticointcart.jpgHi Vetic

Hi Vetic

tolnaftate OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49873-056
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Tolnaftate TOLNAFTATE 1 g

Inactive Ingredients

Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
diethyl sebacate
potassium stearate
CETETH-20
SODIUM LAURYL SULFATE
GLYCERYL MONOSTEARATE
UREA
DIMETHICONE
Zinc Oxide
white wax
stearyl alcohol
POLIDOCANOL
LIGHT MINERAL OIL
propylene glycol
water
SILICON

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 TUBE
2 NDC:49873-056-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 1996-10-25


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Be sure to consult your doctor before taking any medication!
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