Flocean INTIMATE COMFORT by Jiangxi Hemei Pharmaceutical Co., Ltd 84010-241 update

Flocean INTIMATE COMFORT by

Drug Labeling and Warnings

Flocean INTIMATE COMFORT by is a Otc medication manufactured, distributed, or labeled by Jiangxi Hemei Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FLOCEAN INTIMATE COMFORT- micronized estriol 0.1% intimate comfort cream 
Jiangxi Hemei Pharmaceutical Co., Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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84010-241 update

Active Ingredient

Micronized Estriol 0.1%

Purpose

Relieves Vaginal Dryness

Use

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

Warnings

1.For lntimate use only,not for oral use.
2.The product should not be use as a substitute for medicinesad medical devices.

Do not use

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

When Using

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

Stop Use

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

Ask Doctor

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

Keep Oot Of Reach Of Children

This product is for adult use onlv.

Directions

.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 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

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

Inactive ingredients

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.

PRINCIPAL DISPLAY PANEL

FLOCEAN INTIMATE COMFORT 
micronized estriol 0.1% intimate comfort cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-241
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESTRIOL (UNII: FB33469R8E) (ESTRIOL - UNII:FB33469R8E)	ESTRIOL	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
OLIVE OIL (UNII: 6UYK2W1W1E)
CARBOMER (UNII: 0A5MM307FC)
COCONUT OIL (UNII: Q9L0O73W7L)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-241-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/27/2025	02/08/2026

Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(84010-241)

Revised: 2/2026

Document Id: 4a45cd62-ee3e-25a8-e063-6294a90ae0eb

34390-5

Set id: 46e9d86b-a556-6c93-e063-6294a90acc33

Version: 3

Effective Time: 20260207