FDA.reportPublic FDA data

85248-138update

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-06-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-06-17 05:10:15

Label at a glance#

ProductBeilloso Balanitis Relief
Active ingredientMICONAZOLE NITRATE
Label structure13 sections

Dosage and administration

·Dispense 2 pumps of cream onto clean fingers.·Apply to affected area on clean, dry skin 1-2x daily,gently massage until fully absorbed.·For first-time users: Do a small patch test before full use

Storage and handling

Store at 59-86°F(15-30°C）

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

reduce inflammation.soothe irritated skin

Use

INDICATIONS & USAGE SECTION

Helps relieve redness, itching & irritation from balanitis,and soothes discomfort from other fungal skin conditions in sensitive areas.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

under 2 years of age unless directed by a doctor.

When Using

OTC - WHEN USING SECTION

avoid contact with the eyes.If contact occurs. rinse the eyes very thoroughly with water

Stop Use

OTC - STOP USE SECTION

if irritation occurs,symptoms perist for more than 2 weeks,or symptoms worsen after initial improvement.

Ask Doctor

OTC - ASK DOCTOR SECTION

if irritation occurs,symptoms perist for more than 2 weeks,or symptoms worsen after initial improvement.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

·Dispense 2 pumps of cream onto clean fingers.·Apply to affected area on clean, dry skin 1-2x daily,gently massage until fully absorbed.·For first-time users: Do a small patch test before full use

Other information

STORAGE AND HANDLING SECTION

Store at 59-86°F(15-30°C）

Inactive ingredients

INACTIVE INGREDIENT SECTION

water,allantoin.beeswax,cedarwood oil, cottonseed oil, jojoba oil lavender oil, magnesium oxide,MCT oil, silver stearate, zinc oxide.


PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-13885248-138-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
LAVENDER OILZBP1YXW0H8IACT
WATER059QF0KO0RIACT
JOJOBA OIL724GKU717MIACT
CEDRUS ATLANTICA BARK OILZX5QRE4U60IACT
ZINC OXIDESOI2LOH54ZIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
MAGNESIUM OXIDE3A3U0GI71GIACT
SILVER STEARATE4H6PCL92ZNIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COTTONSEED OILH3E878020NIACT
BEESWAX2ZA36H0S2VIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-02-09full-release2026-06-01 01:37:51

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
Beilloso Balanitis ReliefMICONAZOLE NITRATE 2% BALANITIS RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4a71c26f-dee5-7b7f-e063-6294a90afcc12026-06-14WarningsExact identifier
ndc (package): 85248-138-01
ndc (product): 85248-138
ndc11 (package): 85248013801
spl id: 54428bfa-6c84-0067-e063-6394a90a11c4
spl set id: 4a71c26f-dee5-7b7f-e063-6294a90afcc1

Reported adverse events (FAERS/openFDA)#

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