MedPath

MYEVER

Approved
Approval ID

3ed85485-a441-4c05-e063-6394a90afef5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

Hubei Redrui Building Materials Co., Ltd.

DUNS: 617973213

Products 1

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

Estriol Cream

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code87066-5915
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Estriol Cream
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (33)

AQUAInactive
Quantity: 77.9555 g in 100 g
Code: 059QF0KO0R
Classification: IACT
AVENA SATIVA (OAT) KERNEL OILInactive
Quantity: 0.1 g in 100 g
Code: 3UVP41R77R
Classification: IACT
PALMITOYL TRIPEPTIDE-1Inactive
Quantity: 0.0015 g in 100 g
Code: RV743D216M
Classification: IACT
PALMITOYL TETRAPEPTIDE-7Inactive
Quantity: 0.0015 g in 100 g
Code: Q41S464P1R
Classification: IACT
SODIUM BENZOATEInactive
Quantity: 0.15 g in 100 g
Code: OJ245FE5EU
Classification: IACT
ERYNGIUM MARITIMUM ROOTInactive
Quantity: 0.1 g in 100 g
Code: OSE7C1M67D
Classification: IACT
VITIS VINIFERA (GRAPE) SEED OILInactive
Quantity: 4 g in 100 g
Code: 930MLC8XGG
Classification: IACT
SOY ISOFLAVONESInactive
Quantity: 0.3 g in 100 g
Code: 71B37NR06D
Classification: IACT
CIMICIFUGA RACEMOSA ROOTInactive
Quantity: 0.1 g in 100 g
Code: K73E24S6X9
Classification: IACT
ESTRIOLActive
Quantity: 0.2 g in 100 g
Code: FB33469R8E
Classification: ACTIB
POLYGONUM CUSPIDATUM ROOTInactive
Quantity: 0.35 g in 100 g
Code: 7TRV45YZF7
Classification: IACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OILInactive
Quantity: 2.8 g in 100 g
Code: 724GKU717M
Classification: IACT
CRITHMUM MARITIMUMInactive
Quantity: 0.1 g in 100 g
Code: J7IHY79BKY
Classification: IACT
BUTYLENE GLYCOLInactive
Quantity: 4.5 g in 100 g
Code: 3XUS85K0RA
Classification: IACT
PUNICA GRANATUM FRUIT JUICEInactive
Quantity: 0.1 g in 100 g
Code: 99S671U9KB
Classification: IACT
MYRICETINInactive
Quantity: 0.02 g in 100 g
Code: 76XC01FTOJ
Classification: IACT
DIOSCOREA OPPOSITIFOLIA (WILD YAM) ROOTInactive
Quantity: 0.5 g in 100 g
Code: 29CIF30B1Z
Classification: IACT
ASIATICOSIDEInactive
Quantity: 0.2 g in 100 g
Code: PKO39VY215
Classification: IACT
HYALURONIC ACIDInactive
Quantity: 0.05 g in 100 g
Code: S270N0TRQY
Classification: IACT
SODIUM HYALURONATEInactive
Quantity: 0.12 g in 100 g
Code: YSE9PPT4TH
Classification: IACT
PALMITOYL PENTAPEPTIDE-4Inactive
Quantity: 0.0015 g in 100 g
Code: KK181SM5JG
Classification: IACT
TOCOPHEROLInactive
Quantity: 0.25 g in 100 g
Code: R0ZB2556P8
Classification: IACT
GLABRIDINInactive
Quantity: 0.02 g in 100 g
Code: HOC5567T41
Classification: IACT
POTASSIUM SORBATEInactive
Quantity: 0.18 g in 100 g
Code: 1VPU26JZZ4
Classification: IACT
GINKGO BILOBA LEAFInactive
Quantity: 0.05 g in 100 g
Code: 19FUJ2C58T
Classification: IACT
PUERARIA MONTANA VAR. LOBATA ROOTInactive
Quantity: 0.3 g in 100 g
Code: PET93F4I3C
Classification: IACT
GLYCERINInactive
Quantity: 3.2 g in 100 g
Code: PDC6A3C0OX
Classification: IACT
COCO-GLUCOSIDEInactive
Quantity: 1.5 g in 100 g
Code: ICS790225B
Classification: IACT
TRIFOLIUM PRATENSE (CLOVER) FLOWERInactive
Quantity: 0.1 g in 100 g
Code: 4JS0838828
Classification: IACT
PANAX GINSENG ROOTInactive
Quantity: 0.1 g in 100 g
Code: CUQ3A77YXI
Classification: IACT
SQUALANEInactive
Quantity: 2.5 g in 100 g
Code: GW89575KF9
Classification: IACT
CAMELLIA SINENSIS LEAFInactive
Quantity: 0.1 g in 100 g
Code: W2ZU1RY8B0
Classification: IACT
CITRUS BIOFLAVONOIDSInactive
Quantity: 0.05 g in 100 g
Code: BD70459I50
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Box Front Panel

MYEVER INTIMATE ESTRIOL CREAM Package

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/15/2025

Uses

  • Temporarily relieves external vulvar dryness
  • Helps prevent and temporarily protects irritated skin.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/15/2025

Active ingredient(s)

Estriol 0.2%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/15/2025

Purpose(s)

Skin Protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 9/15/2025

Warnings

For external use only.

Do not use

  • If you are pregnant or breast-feeding.
  • On minors under 18 years of age.
  • If you have a known sensitivity to estrogen or a hormone-related condition (e.g., breast cancer, endometriosis).
  • On open wounds, swollen areas, rashes, or active infections.

When using this product

Avoid contact with eyes.

Stop use and ask a doctor if

  • A burning sensation, itching, or redness occurs and persists.
  • Condition worsens or symptoms last more than 7 days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 9/15/2025

Pregnancy or breast feeding section

Do not use if pregnant or breast-feeding.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/15/2025

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/15/2025

Directions

  1. Cleanse hands and the external vulvar area with a mild, soap-free cleanser and pat dry.
  2. Apply a pea-sized amount (approx. 0.3 g) to the fingertip.
  3. Gently apply and massage into the dry areas of the vulva in a circular motion until fully absorbed.
  4. After an initial treatment of 2-3 weeks, reduce frequency to a maintenance level (e.g., twice a week).

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/15/2025

Other information

  • Store in a cool, dry place below 25°C (77°F).
  • Avoid direct sunlight and high humidity.
  • Use within 6 months after opening.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/15/2025

Inactive ingredients

AQUA, BUTYLENE GLYCOL, GLYCERIN, VITIS VINIFERA (GRAPE) SEED OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SQUALANE, COCO-GLUCOSIDE, TOCOPHEROL, ASIATICOSIDE, SOY ISOFLAVONES, DIOSCOREA OPPOSITIFOLIA (WILD YAM) ROOT, POLYGONUM CUSPIDATUM ROOT, PUERARIA MONTANA VAR. LOBATA ROOT, HYALURONIC ACID, SODIUM HYALURONATE, SODIUM BENZOATE, POTASSIUM SORBATE, CIMICIFUGA RACEMOSA ROOT, PUNICA GRANATUM FRUIT JUICE, TRIFOLIUM PRATENSE (CLOVER) FLOWER, CAMELLIA SINENSIS LEAF EXTRACT, PANAX GINSENG ROOT, AVENA SATIVA (OAT) KERNEL OIL, PALMITOYL PENTAPEPTIDE-4, PALMITOYL TRIPEPTIDE-1, PALMITOYL TETRAPEPTIDE-7, CITRUS BIOFLAVONOIDS, GLABRIDIN, GINKGO BILOBA LEAF, MYRICETIN, CRITHMUM MARITIMUM, ERYNGIUM MARITIMUM ROOT

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/15/2025

Questions or comments?

934-935-7135 / Rangelcervel824@gmail.com

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MYEVER - FDA Drug Approval Details