FDA.reportPublic FDA data

87278-010 Estriol Cream

Manufacturer
Guangxi Keyun E-commerce Co., Ltd.
Effective date
2026-08-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-09-01 13:02:29

Label at a glance#

ProductEstriol Cream
Active ingredientESTRIOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Estriol 0.2%

OTC - PURPOSE SECTION

Hormone Balance

INDICATIONS & USAGE SECTION

Helps maintain hormonal balance. May help ease symptoms associated with menopause.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use if pregnant, nursing, or trying to conceive.

OTC - WHEN USING SECTION


Avoid contact with eyes.
If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

If irritation or rash develops, discontinue use and consult a health care provider.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children.
If swallowed, seek medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Take 2 pumps of this product onto your fingertips Apply cream evenly to the intimate area (inner labia and perineal region) Wait for 20 minutes until the cream is fully absorbed. Precautions Target audience: For adult women only.

INACTIVE INGREDIENT SECTION

Butylene Glycol
Glycerin
Shea Butter
Cetearyl Alcohol
Sunflower Seed Oil
Bisabolol
Tocopheryl Acetate
Lactobacillus Ferment
Dipotassium Glycyrrhizate
Carbomer
Hydroxyphenyl Propamidobenzoic Acid
Xanthan Gum
Magnolia Officinalis (Magnolia) Bark Extract
Sodium Hyaluronate
Portulaca Oleracea (PORTULACA OLERACEA) Extract
Phenoxyethanol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabel

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
87278-01087278-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ESTRIOLFB33469R8EACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
SODIUM HYALURONATEYSE9PPT4THIACT
LIMOSILACTOBACILLUS FERMENTUM2C1F12C6APIACT
XANTHAN GUMTTV12P4NEEIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HYDROXYPHENYL PROPAMIDOBENZOIC ACID25KRT26H77IACT
CETEARYL ALCOHOL2DMT128M1SIACT
SUNFLOWER OIL3W1JG795YIIACT
DIPOTASSIUM GLYCYRRHIZATECA2Y0FE3FXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
PORTULACA OLERACEA WHOLED5J3623SV2IACT
BISABOLOL24WE03BX2TIACT
MAGNOLIA OFFICINALIS BARK5M609NV974IACT
SHEA BUTTERK49155WL9YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-07-23daily-update2026-07-25 05:10:06
22026-07-07weekly-update2026-07-17 21:43:46
12026-03-26full-release2026-06-01 01:51:59

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
Estriol CreamESTRIOLGuangxi Keyun E-commerce Co., Ltd.4deadcb6-0d46-bdd7-e063-6294a90a26d72026-08-27WarningsExact identifier
ndc (package): 87278-010-01
ndc (product): 87278-010
ndc11 (package): 87278001001
spl id: 5a05027d-03f6-b688-e063-6394a90adc3f
spl set id: 4deadcb6-0d46-bdd7-e063-6294a90a26d7

Reported adverse events (FAERS/openFDA)#

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