HI VETIC- tolnaftate ointment 
Sato Pharmaceutical Co., Ltd.

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Hi Vetic Ointment

Active ingredient    Tolnaftate 1%

Purpose    Antifungal

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.

hiveticointcart.jpg Carton

HI VETIC 
tolnaftate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-056-011 in 1 CARTON10/25/1996
115 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00510/25/1996
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-056) , label(49873-056) , pack(49873-056)

Revised: 12/2023
Document Id: 0bde5831-2b16-2948-e063-6394a90ad473
Set id: 2096e241-3ed3-49cd-88c4-71db1fd2934a
Version: 7
Effective Time: 20231206
 
Sato Pharmaceutical Co., Ltd.