HI VETIC- tolnaftate ointment

Hi Vetic by

Drug Labeling and Warnings

Hi Vetic by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient    Tolnaftate 1%

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

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.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HI VETIC 
tolnaftate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-056
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
tolnaftate (UNII: 06KB629TKV) (tolnaftate - UNII:06KB629TKV)	tolnaftate	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
diethyl sebacate (UNII: I41B9FJK6V)
potassium stearate (UNII: 17V812XK50)
CETETH-20 (UNII: I835H2IHHX)
sodium lauryl sulfate (UNII: 368GB5141J)
glyceryl monostearate (UNII: 230OU9XXE4)
urea (UNII: 8W8T17847W)
dimethicone (UNII: 92RU3N3Y1O)
zinc oxide (UNII: SOI2LOH54Z)
white wax (UNII: 7G1J5DA97F)
stearyl alcohol (UNII: 2KR89I4H1Y)
POLIDOCANOL (UNII: 0AWH8BFG9A)
light mineral oil (UNII: N6K5787QVP)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
silicon (UNII: Z4152N8IUI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-056-01	1 in 1 CARTON	10/25/1996
1		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	10/25/1996

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-056) , label(49873-056) , pack(49873-056)