Flocean INTIMATE COMFORT

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-02-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:37:24

Label at a glance#

ProductFlocean INTIMATE COMFORT
Active ingredientESTRIOL
Label structure13 sections

Dosage and administration

·Dispense 2 pumps of cream onto clean fingers. ·Smooth over the inner lips and perineum.(Not for internal use). ·Apply once or twice a day, apply at bedtime while lying down. ·Wait 20 minutes for the cream to deeply absorb for maximum overnight benefit.

Storage and handling

Store in a dry and cool place at 20°C-25°C(68°F-77°F).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Micronized Estriol 0.1%

Purpose

OTC - PURPOSE SECTION

Relieves Vaginal Dryness

Use

INDICATIONS & USAGE SECTION

·Provides temporary relief from Intimate dryness and discomfort.
·Moisturizes and soothes the Intimate area.

Warnings

WARNINGS SECTION

1.For lntimate use only,not for oral use.

2.The product should not be used as a substitute for medicines and medical devices.

Do not use

OTC - DO NOT USE SECTION

Do not use if you are pregnant,during menstruation, or breastfeeding.

When Using

OTC - WHEN USING SECTION

lf this is the first time you are experiencing vaginal dryness or discomfort. consult your healthcare provider.

Stop Use

OTC - STOP USE SECTION

·you experience abdominal pain,fever, chills,nausea.vomiting, of foul-smelling discharge.
·symptoms worsen or do not improve within 7 days.

Ask Doctor

OTC - ASK DOCTOR SECTION

·you experience abdominal pain.fever, chills, nausea, vomiting or foul-smelling discharge.
·symptoms worsen or do not improve within 7 days.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

This product is for adult use onlv.

Directions

DOSAGE & ADMINISTRATION SECTION

·Dispense 2 pumps of cream onto clean fingers. ·Smooth over the inner lips and perineum.(Not for internal use). ·Apply once or twice a day, apply at bedtime while lying down.
·Wait 20 minutes for the cream to deeply absorb for maximum overnight benefit.

Other information

STORAGE AND HANDLING SECTION

Store in a dry and cool place at 20°C-25°C(68°F-77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Vegetable Glycerin, Aloe Vera Gel.Caprylic/Capric Triglyceride.Stearic Acid, Olive Oil.Coconut Oil.Shea Butter, Sunflower Lecithin,Methylsulfonylmethane(MsM).Stearyl Alcohol,Isopropyl Palmitate,Allantoin.Carbomer, Sodium Bicarbonate, Herbal-Active (Natural Preservative)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.10.1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136979843980401GTIN-13: 6979843980401
EAN-13: 6979843980401
GTIN storage (14 digits): 06979843980401
2d5136102bac41750b2d73d4d95a38c8.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-055-01Flocean INTIMATE COMFORT30 mL in 1 BOTTLECREAM301

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
85248-05585248-055-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flocean INTIMATE COMFORTMICRONIZED ESTRIOL 0.1% INTIMATE COMFORTJiangxi Yudexi Pharmaceutical Co., LTD4a2299fe-d69a-51c0-e063-6294a90a93572026-02-06WarningsExact identifier
ndc (package): 85248-055-01
ndc (product): 85248-055
ndc11 (package): 85248005501
spl id: 4a2299fe-d69b-51c0-e063-6294a90a9357
spl set id: 4a2299fe-d69a-51c0-e063-6294a90a9357

Reported adverse events (FAERS/openFDA)#

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