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Estrogen Estriol Cream

85248-008 Estrogen Estriol Cream

Approved
Approval ID

f5412f40-0324-4949-a429-bc7b029f101e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

Jiangxi Yudexi Pharmaceutical Co., LTD

DUNS: 455662836

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

5% Estriol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85248-008
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
5% Estriol
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (15)

PHELLODENDRON CHINENSE WHOLEInactive
Code: QKA3ZK8IIE
Classification: IACT
CNIDIUM MONNIERI WHOLEInactive
Code: GYR30735RE
Classification: IACT
3-METHYL-5-HEPTANONE OXIMEInactive
Code: XHN6C9A7U3
Classification: IACT
SCLEROMITRION DIFFUSUMInactive
Code: 291PPU5K9I
Classification: IACT
ALOEInactive
Code: V5VD430YW9
Classification: IACT
CHLORHEXIDINE ACETATEInactive
Code: 5908ZUF22Y
Classification: IACT
VIOLA PHILIPPICA WHOLEInactive
Code: O176VC3N54
Classification: IACT
CARTHAMUS TINCTORIUS FLOWER OILInactive
Code: SDQ136WIM5
Classification: IACT
SALVIA MILTIORRHIZA WHOLEInactive
Code: 714783Y9Z0
Classification: IACT
SOPHORA FLAVESCENS WHOLEInactive
Code: X8KX602M5L
Classification: IACT
BORNEOLInactive
Code: M89NIB437X
Classification: IACT
ANGELICA SINENSIS WHOLEInactive
Code: 697D19QDBN
Classification: IACT
LIGUSTICUM SINENSE SUBSP. CHUANXIONG WHOLEInactive
Code: CAX256379F
Classification: IACT
ESTRIOLActive
Quantity: 5 g in 100 g
Code: FB33469R8E
Classification: ACTIB
AQUAInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/15/2025

Estrogen Estriol Cream

Advanced Bioidentical
Estrogen Estriol Cream

2-Month Supply

Net Wt. 50 g / 1.7 oz. U.S.

Directions

Dispense two pumps of cream onto clean fingertips. For optimal results, prioritize applying to intimate areas and gently massage until absorbed. Wait 20 minutes before using the restroom or engaging in sexual activity. The cream can also be applied to the neck, chest, inner wrist, thighs, or abdomen. Use once or twice daily.

Warnings

For external use only. Do not ingest. Avoid direct contact with eyes. In case of direct contact with eyes, rinse immediately with plenty of clean water.

Do not use on damaged or wounded skin. Do not use if you suffer from any skin disease or are allergic to any of the ingredients. Discontinue use if irritation occurs. Do not exceed recommended usage.

Keep Out Of Reach Of Children

Inactive ingredients

Aqua, Carthamus Tinctorius (Safflower) Oil, Salvia Miltiorrhiza, Sophora Flavescens, Estriol, Ligusticum Chuanxiong, Borneol, Viola Yedoensis, Angelica Sinensis, Cnidium Monnieri, Stemona, Phellodendron, Aloe, Oldenlandia Diffusa, Chlorhexidine Acetate

Plant-Based Hormonal Support
Relieves Menopausal Symptoms
Free from Preservatives

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