Hi Vetic Ointment

Manufacturer
Sato Pharmaceutical Co., Ltd.
Effective date
2023-12-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:03:21

Label at a glance#

ProductHi Vetic
Active ingredientTOLNAFTATE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient    Tolnaftate 1%

OTC - PURPOSE SECTION

Purpose    Antifungal

INDICATIONS & USAGE SECTION

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 SECTION

Warnings
For external use only

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product ■ avoid contact with the eyes

OTC - STOP USE SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

hiveticointcart.jpg CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1236105hiVETIC 1 % Topical OintmentPSN7
199126tolnaftate 1 % Topical OintmentPSN7
1236105tolnaftate 0.01 MG/MG Topical Ointment [hiVETIC]SBD7
199126tolnaftate 0.01 MG/MG Topical OintmentSCD7
1236105hiVETIC 0.01 MG/MG Topical OintmentSY7
1236105hiVETIC 1 % Topical OintmentSY7
199126tolnaftate 1 % Topical OintmentSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d2ef081-4f0c-4669-81e8-32b263669a0aProduct name120230801
af534dc0-c9e5-19a6-693c-e7ad53714660Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-056-01Hi Vetic1 in 1 CARTONOINTMENT17
49873-056-01Hi Vetic15 g in 1 TUBEOINTMENT157

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-056HI VETIC (TOLNAFTATE) OINTMENT [SATO PHARMACEUTICAL CO., LTD.]7Current NDC, Legacy NDC, 2 package rows20231207_2096e241-3ed3-49cd-88c4-71db1fd2934a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
tolnaftateACTIVE INGREDIENT06KB629TKV4
tolnaftateACTIVE MOIETY06KB629TKV4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3114
CETETH-20INACTIVE INGREDIENTI835H2IHHX4
diethyl sebacateINACTIVE INGREDIENTI41B9FJK6V4
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O4
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE44
light mineral oilINACTIVE INGREDIENTN6K5787QVP4
POLIDOCANOLINACTIVE INGREDIENT0AWH8BFG9A4
potassium stearateINACTIVE INGREDIENT17V812XK504
propylene glycolINACTIVE INGREDIENT6DC9Q167V34
siliconINACTIVE INGREDIENTZ4152N8IUI4
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141J4
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1Y4
ureaINACTIVE INGREDIENT8W8T17847W4
waterINACTIVE INGREDIENT059QF0KO0R4
white waxINACTIVE INGREDIENT7G1J5DA97F4
zinc oxideINACTIVE INGREDIENTSOI2LOH54Z4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49873-05649873-056-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 34 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JOINTMENT / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
diethyl sebacateDIETHYL SEBACATEI41B9FJK6VSOLUTION / TOPICAL24 %w/wExact identifier — unii+route
4 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
white waxWHITE WAX7G1J5DA97FOINTMENT / TOPICAL2100 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETETH-20CETETH-20I835H2IHHXLOTION / TOPICAL2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311LOTION / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
diethyl sebacateDIETHYL SEBACATEI41B9FJK6VSOLUTION / TOPICAL24 %w/wExact identifier — unii+route
4 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii+route
6 equally ranked IID candidates
diethyl sebacateDIETHYL SEBACATEI41B9FJK6VLOTION / TOPICAL212 mgExact identifier — unii+route
4 equally ranked IID candidates
ureaUREA8W8T17847WSYSTEM / TOPICAL840 mgExact identifier — unii+route
2 equally ranked IID candidates
CETETH-20CETETH-20I835H2IHHXSOLUTION / TOPICAL2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
CETETH-20CETETH-20I835H2IHHXSOLUTION / TOPICAL2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
ureaUREA8W8T17847WSYSTEM / TOPICAL840 mgExact identifier — unii+route
2 equally ranked IID candidates
CETETH-20CETETH-20I835H2IHHXCREAM / TOPICAL429 mgExact identifier — unii+route
6 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4OINTMENT / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
siliconSILICONZ4152N8IUICREAM / TOPICAL0.4 %w/wExact identifier — unii+route
2 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4OINTMENT / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
zinc oxideZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii+route
2 equally ranked IID candidates
diethyl sebacateDIETHYL SEBACATEI41B9FJK6VLOTION / TOPICAL212 mgExact identifier — unii+route
4 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii+route
6 equally ranked IID candidates
siliconSILICONZ4152N8IUICREAM / TOPICAL0.4 %w/wExact identifier — unii+route
2 equally ranked IID candidates
stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YOINTMENT / TOPICAL569 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETETH-20CETETH-20I835H2IHHXLOTION / TOPICAL2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JOINTMENT / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YOINTMENT / TOPICAL569 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
zinc oxideZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii+route
2 equally ranked IID candidates
CETETH-20CETETH-20I835H2IHHXCREAM / TOPICAL429 mgExact identifier — unii+route
6 equally ranked IID candidates
white waxWHITE WAX7G1J5DA97FOINTMENT / TOPICAL2100 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311LOTION / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hi VeticTOLNAFTATESato Pharmaceutical Co., Ltd.2096e241-3ed3-49cd-88c4-71db1fd2934a2023-12-06WarningsExact identifier
ndc (package): 49873-056-01
ndc (product): 49873-056
ndc11 (package): 49873005601
spl id: 0bde5831-2b16-2948-e063-6394a90ad473
spl set id: 2096e241-3ed3-49cd-88c4-71db1fd2934a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.