HI VETIC- tolnaftate solution

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]

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
Extremely flammable. Keep away from fire or flame

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

DOSAGE & ADMINISTRATION

Directions
■for the tratment 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

OTHER SAFETY INFORMATION

Other information   
■keep tightly closed
■cap bottle tightly and store at room temperature away from heat

INACTIVE INGREDIENT

Inactive ingredients  acetone, citric acid, diethyl sebacate, fragrance, isopropyl alcohol, lauromacrogol 400, propyl gallate, water

ACTIVE INGREDIENT

Active ingredient
Tolnaftate 1%

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HI VETIC 
tolnaftate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-050
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 mL

Inactive Ingredients
Ingredient Name	Strength
acetone (UNII: 1364PS73AF)
citric acid monohydrate (UNII: 2968PHW8QP)
diethyl sebacate (UNII: I41B9FJK6V)
isopropyl alcohol (UNII: ND2M416302)
POLIDOCANOL (UNII: 0AWH8BFG9A)
propyl gallate (UNII: 8D4SNN7V92)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-050-02	1 in 1 CARTON	08/14/1990
1		20 mL in 1 BOTTLE; 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	08/14/1990

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

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-050) , label(49873-050) , pack(49873-050)