FDA.reportPublic FDA data

Update-85398-024-01

Manufacturer
Beautivity LLC
Effective date
2026-06-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-07-17 21:37:15

Label at a glance#

ProductRingworm Treatment Cream
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

OTC - PURPOSE SECTION

Antifungal

DOSAGE & ADMINISTRATION SECTION

  • Cures most athlete's foot, jock itch, and ringworm.
  • Relieves itching, burning, cracking, scaling & discomfort which accompany these conditions.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

avoid contact with eyes.

OTC - ASK DOCTOR SECTION

  • Irritation occurs
  • There is no improvementwithin 4 weeks (for athlete's foot andringworm) or 2 weeks (for jock itch).
  • Do not use for diaper rash.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep this and all drugs out of reach of children.
  • If swallowed, get medical help or contacta Poison Control Center right away.

INDICATIONS & USAGE SECTION

  • Clean the affected area with soap & warm water & dry thoroughly.
  • Apply a thin layer over the affected areatwice daily (morning and night), or asdirected by a doctor.
  • Supervise childrenin the use of the product.
  • For jock itch& psoriasis, use daily for 2 weeks. Forringworm and athlete's foot, use daily for 4 weeks.
  • If the condition persists longer, consult a doctor.
  • This productis not effective on the scalp or nails.

OTHER SAFETY INFORMATION

  • Store at 20-Cto 25C(68Fto 77eF).
  • Close the cap tightly after use.

INACTIVE INGREDIENT SECTION

Water, Dimethicone, Mineral Oil, Petrolatum,Glycerin, Glyceryl Monostearate, Menthol,Zanthoxylum Bungeanum Fruit Extract,Viola Yedoensis Extract, Euphorbia Hirta Extract, Murraya Paniculata Leaf Extract,Sophora Flavescens Root Extract, Cnidium Monnieri Fruit Extract, Smilax Glabra Root Extract, Ophiopogon Japonicus Root Extract, Phellodendron AmurenseBark Extract, Gleditsia Sinensis Thorn Extract, Stemona Sessilifolia Root Extract, Borneol, Chlorhexidine Acetate, Dictamnus Dasycarpus Root Bark Extract, Kochia Scoparia Fruit Extract.

NONTERATOGENIC EFFECTS SECTION

servcie@hermonhealth.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed Product Concepts#

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

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85398-02485398-024-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORNEOLM89NIB437XIACT
CHLORHEXIDINE ACETATE5908ZUF22YIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
MINERAL OILT5L8T28FGPIACT
MENTHOLL7T10EIP3AIACT
PHELLODENDRON AMURENSE BARKPBG27B754GIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
ZANTHOXYLUM BUNGEANUM FRUIT3CIP16A418IACT
VIOLA PHILIPPICA WHOLEO176VC3N54IACT
MURRAYA PANICULATA LEAFY TWIGVO9X9681W9IACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
STEMONA SESSILIFOLIA ROOTEKG8030U4NIACT
GLEDITSIA SINENSIS THORN26LKE578NYIACT
EUPHORBIA HIRTAL13YF113GNIACT
SMILAX GLABRA WHOLEH51N91QNEBIACT
OPHIOPOGON JAPONICUS ROOT90PS6JV9GZIACT
DICTAMNUS DASYCARPUS ROOT BARKLA97176ILSIACT
GLYCERINPDC6A3C0OXIACT
PETROLATUM4T6H12BN9UIACT
CNIDIUM MONNIERI FRUITV1IA3S3CUSIACT
BASSIA SCOPARIA FRUIT04W97Z676YIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-03-02full-release2026-06-01 01:48:33
12026-01-10monthly-update2026-06-03 17:53:11

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ringworm Treatment CreamMICONAZOLE NITRATE 2%Beautivity LLC4805462b-aec6-78fe-e063-6394a90ae0662026-06-29WarningsExact identifier
ndc (package): 85398-024-01
ndc (product): 85398-024
ndc11 (package): 85398002401
spl id: 55675f82-4b8a-44de-e063-6294a90a567e
spl set id: 4805462b-aec6-78fe-e063-6394a90ae066
Hermon Ringworm Treatment KitMICONAZOLE NITRATE 2% AND CLOTRIMAZOLE 1%Beautivity LLC4a9d9c6e-0e0f-d539-e063-6294a90acb572026-02-12WarningsExact identifier
ndc (package): 85398-024-01
ndc11 (package): 85398002401

Reported adverse events (FAERS/openFDA)#

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