FDA.reportPublic FDA data

87976-001

Manufacturer
Guangzhou Shunfei Network Technology Co., Ltd.
Effective date
2026-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-03 03:02:05

Label at a glance#

ProductEstriora Cream
Active ingredientESTRIOL, ESTRADIOL
Label structure14 sections

Dosage and administration

• Use only as directed.• Apply the recommended amount according to product instructions.• Follow the dosing schedule provided by your healthcare professional.

Storage and handling

Store at 20° to 25°C (68° to 77°F).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Estriol 0.2%
Estradiol 0.01%

Purpose

OTC - PURPOSE SECTION

Hormone Support

Use

INDICATIONS & USAGE SECTION

• Helps relieve vaginal dryness associated with decreased estrogen levels.<br>• Provides estrogen support for feminine care needs.

Warnings

WARNINGS SECTION

For external use only

Do not use if you have had:
• Breast cancer
• Estrogen-dependent cancer
• Unexplained vaginal bleeding

Ask a doctor before use if you:
• Have a history of blood clots
• Have heart disease
• Have liver problems

Stop use and ask a doctor if:
• Unusual vaginal bleeding occurs
• Severe discomfort develops

Do not use

OTC - DO NOT USE SECTION

Do not use if you have had:
• Breast cancer
• Estrogen-dependent cancer
• Unexplained vaginal bleeding

When Using

OTC - WHEN USING SECTION

Ask a doctor before use if you:
• Have a history of blood clots
• Have heart disease
• Have liver problems

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if:
• Unusual vaginal bleeding occurs
• Severe discomfort develops

Ask Doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have a history of blood clots, heart disease, or liver problems.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

• Use only as directed.<br>• Apply the recommended amount according to product instructions.<br>• Follow the dosing schedule provided by your healthcare professional.

Other information

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Propylene Glycol, Stearyl Alcohol, Cetyl Alcohol, Glycerin, Polysorbate 60, Sodium Citrate, Preservatives

Questions

OTC - QUESTIONS SECTION

1-858-905-0218

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackPack

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87976-00187976-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ESTRIOLFB33469R8EACTIB
ESTRADIOL4TI98Z838EACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 60CAL22UVI4MIACT
SODIUM CITRATE1Q73Q2JULRIACT

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
Estriora CreamESTRIOL AND ESTRADIOL CREAMGuangzhou Shunfei Network Technology Co., Ltd.5a53c026-aa7c-6c09-e063-6394a90a36e12026-08-31WarningsExact identifier
ndc (package): 87976-001-01
ndc (product): 87976-001
ndc11 (package): 87976000101
spl id: 5a53c026-aa7d-6c09-e063-6394a90a36e1
spl set id: 5a53c026-aa7c-6c09-e063-6394a90a36e1

Reported adverse events (FAERS/openFDA)#

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