85398-022 Initial-73

Manufacturer
Beautivity LLC
Effective date
2026-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:07

Label at a glance#

ProductHermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock Itch
Active ingredientTOLNAFTATE, MICONAZOLE NITRATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2% (Cream)
Clotrimazole 1% (Soap Bar)

OTC - PURPOSE SECTION

Antifungal

DOSAGE & ADMINISTRATION SECTION

  • For effective treatment of most athlete's foot, ringworm and jock itch.
  • For effective relief of itching, burning and cracking skin.

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

Avoid contact with the eye

OTC - STOP USE SECTION

iritationoccurs or if the is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.

OTC - DO NOT USE SECTION

on children under 2 of age except under the advice and supervision of a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Cream:

  • clean the affected area and dry thoroughly.
  • apply a thin layer of the product over affected area twice daily(morning and night) or as directed by a doctor.
  • supervise children in the use of this product.
  • for athlete's foot, pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes, and 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.
  • this product is not effective on the scalp or nails

Soap Bar:

  • Wash affected area well and let product sit 2-3 minutes before rinsing.
  • Make sure to dry affected area thoroughly.
  • Supervise children in the use of this product.
  • For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
  • Use 1-2 times daily. Use dailyfor 4 weeks; if condition persists longer, ask a doctor.
  • This product is not effective on the scalp or nails.

OTHER SAFETY INFORMATION

Store at room temperature 59°-86°F (15°-30°C).

INACTIVE INGREDIENT SECTION

Cream:

Water, Smilax Glabra Root Extract, Sophora Flavescens Root Extract, Cnidium Monnieri Fruit Extract, Kochia Scoparia Fruit Extract, Pseudolarix Amabilis Bark Extract, Dictamnus Dasycarpus Root Bark Extract, Stemona Tuberosa Root Extract, Mentha Arvensis Leaf ERract, Glycyrrhetinic Acid


Soap Bar:

Sucrose, Stearic Acid, Propylene Glycol, Sorbitol, Sodium Palmitate, Water, Glycerin, Butyrospermum Parki(Shea) Butter, Lauric Acid, Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Juice, CocosNucifera (Coconut) Oil, Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN1
1807715tolnaftate 1 % Medicated Bar SoapPSN1
998483miconazole nitrate 20 MG/ML Topical CreamSCD1
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD1
998483miconazole nitrate 2 % Topical CreamSY1
1807715tolnaftate 1 % Medicated Bar SoapSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeq-r.to/TVKITpackage.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-022-01Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock Itch1 in 1 CARTONKIT11
85398-031-01Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock Itch113 g in 1 CARTONSOAP1 g in 1131.13 g in 113g1
85398-032-01Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock Itch60 g in 1 CARTONCREAM1 g in 601.2 g in 60g1

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85398-02285398-022-01
85398-03185398-031-01
85398-03285398-032-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Source Document#

Source XML

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock ItchANTIFUNGAL TREATMENT KITBeautivity LLC4800a93b-7042-827b-e063-6294a90acd952026-03-25WarningsExact identifier
ndc (package): 85398-032-01
ndc (package): 85398-031-01
ndc (package): 85398-022-01
ndc (product): 85398-022
ndc11 (package): 85398002201
ndc11 (package): 85398003101
ndc11 (package): 85398003201
spl id: 4800a93b-7043-827b-e063-6294a90acd95
spl set id: 4800a93b-7042-827b-e063-6294a90acd95
Hermon Jock Itch Antifungal Treatment .Soap. BarTOLNAFTATE 1%Beautivity LLC4dbbf09b-5bc1-501b-e063-6394a90a2a9d2026-03-23WarningsExact identifier
ndc (package): 85398-031-01
ndc (product): 85398-031
ndc11 (package): 85398003101
Hermon Jock Itch Antifungal Treatment CreamMICONAZOLE NITRATE 2%Beautivity LLC4dbc521c-2f5f-9736-e063-6294a90ad85d2026-03-23WarningsExact identifier
ndc (package): 85398-032-01
ndc (product): 85398-032
ndc11 (package): 85398003201

Reported adverse events (FAERS/openFDA)#

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