SPL v1
SPL
SPL Set ID 42e4cc84-7c00-6937-e063-6294a90a0c09
Route
TOPICAL
Published
Effective Date 2025-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Estriol (0.2 g)
Inactive Ingredients
Tocopherol Hyaluronic Acid Glycerin Simmondsia Chinensis (jojoba) Seed Oil Soy Isoflavones Vitis Vinifera (grape) Seed Oil Water Camellia Japonica Seed Oil Butyrospermum Parkii (shea) Oil Cetearyl Alcohol Panthenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-11-06 Until 2026-11-11

Description

ESTRIOL0.2%


Medication Information

Warnings and Precautions

For external use only.For external use only Keep away from fire and flame

Indications and Usage

1. Clean the affected area of the skin.

2. Apply 1-2ml in the area where it is needed.

3. Spread it evenly over the remaining part of the area.

4. Continue to use every day.

Dosage and Administration

Twice each day, (1ml)each time. 15 days supply

Description

ESTRIOL0.2%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.

Section 50570-1

You are under 18 years old. Do not use this product on infants and children. If your skin is red, swollen, inflamed, infected, itchy or painful, do not use it.

You are currently taking other medications to treat your illness. If you have heart disease, consult your doctor before using it.

Section 51727-6

WATER、GLYCERIN、PANTHENOL、CETEARYL ALCOHOL、VITIS VINIFERA (GRAPE) SEED OIL、SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL、CAMELLIA JAPONICA SEED OIL、TOCOPHEROL、ESTRIOL、SOY ISOFLAVONES、HYALURONIC ACID、BUTYROSPERMUM PARKII (SHEA) OIL

Section 51945-4

Section 55105-1

Supplement estrogen to alleviate inflammation

Section 55106-9

ESTRIOL0.2%


Structured Label Content

Indications and Usage (34067-9)

1. Clean the affected area of the skin.

2. Apply 1-2ml in the area where it is needed.

3. Spread it evenly over the remaining part of the area.

4. Continue to use every day.

Dosage and Administration (34068-7)

Twice each day, (1ml)each time. 15 days supply

Warnings and Precautions (34071-1)

For external use only.For external use only Keep away from fire and flame

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.

Section 50570-1 (50570-1)

You are under 18 years old. Do not use this product on infants and children. If your skin is red, swollen, inflamed, infected, itchy or painful, do not use it.

You are currently taking other medications to treat your illness. If you have heart disease, consult your doctor before using it.

Section 51727-6 (51727-6)

WATER、GLYCERIN、PANTHENOL、CETEARYL ALCOHOL、VITIS VINIFERA (GRAPE) SEED OIL、SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL、CAMELLIA JAPONICA SEED OIL、TOCOPHEROL、ESTRIOL、SOY ISOFLAVONES、HYALURONIC ACID、BUTYROSPERMUM PARKII (SHEA) OIL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Supplement estrogen to alleviate inflammation

Section 55106-9 (55106-9)

ESTRIOL0.2%


Advanced Ingredient Data


Raw Label Data

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