Hi Vetic Ointment
FDA Label NDC 49873-056

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Hi Vetic (NDC 49873-056). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

hiveticointPDP.jpg

hiveticointcart.jpg

Carton (Hiveticointcart)

Carton (Hiveticointcart)

* Please review the disclaimer below.