SPL v1
SPL
SPL Set ID 43011898-e114-5fdb-e063-6294a90aaba8
Route
TOPICAL
Published
Effective Date 2025-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Estriol (0.36 g)
Inactive Ingredients
Water Isoflavone Dioscorea Villosa Root Black Cohosh Pomegranate Oat Arginine Reynoutria Japonica Root Brassica Napus Seed Oil Aloe Trifolium Pratense Flower Hyaluronic Acid Panax Ginseng Root Jojoba Oil Aloe Vera Leaf Juice Green Tea Leaf Glycerin Vitamin E Polyethylene Glycol Succinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-07

Description

Micronized Estriol

Purpose

Hormonal Skin Support


Medication Information

Purpose

Hormonal Skin Support

Description

Micronized Estriol

Use

Helps improve skin tone and texture associated with estrogen decline . Supports hydration, firmness, and elasticity in aging skin , Helps relieve menopausal discomforts

Image

Stop Use

if irritation occurs.

if an allergic reaction occurs

Warnings

For external use only.

Direction

Clean and dry the affected area before applying.

Apply a small amount (pea-sized) twice daily or asdirected byahealthcare professional.

Massagegently until fully absorbed.·For topical use only

Ask Doctor

lf you are pregnant, breastfeeding, or takinghormone therapy.’lf you have a history ofhormone-sensitive conditions or cancers.

Do Not Use

On damaged or broken skin (cuts, abrasions ,eczema, or burns).

lfyou have known sensitivity to hormonal or estrogenic ingredients.

Other Information

Store at 20° to 25°C(68° to 77°F).

Protect from excessive heat above 40°C(104°F)

Do not freeze.

Active Ingredient(s)

Micronized Estriol

Inactive Ingredients

Water, Glycerin, Jojoba Seed Oil, Vitamin E, AloeVera, Grape Seed Oil, Camellia Seed Oil,Juice,Soy lsoflavones, Wild Yam Root Extract,Japanese Knotweed Root Extract, Kudzu RootExtract, Black Cohosh Root Extract,Pomegranate Extract, Red Clover Flower Extract,Green Tea Leaf Extract, Ginseng Root Extract, OatExtract, Hyaluronic Acid, Arginine.

Keep Out of Reach of Children

If swallowed, get medical help or contact aPoison Control Centerimmediately.(1-800-222-1222)*Avoid contact with eyes.

lf contact occurs, rinse with water.


Structured Label Content

Use

Helps improve skin tone and texture associated with estrogen decline . Supports hydration, firmness, and elasticity in aging skin , Helps relieve menopausal discomforts

Image

Purpose

Hormonal Skin Support

Stop Use

if irritation occurs.

if an allergic reaction occurs

Warnings

For external use only.

Direction (DIRECTION)

Clean and dry the affected area before applying.

Apply a small amount (pea-sized) twice daily or asdirected byahealthcare professional.

Massagegently until fully absorbed.·For topical use only

Ask Doctor

lf you are pregnant, breastfeeding, or takinghormone therapy.’lf you have a history ofhormone-sensitive conditions or cancers.

Do Not Use (Do not use)

On damaged or broken skin (cuts, abrasions ,eczema, or burns).

lfyou have known sensitivity to hormonal or estrogenic ingredients.

Other Information (Other information)

Store at 20° to 25°C(68° to 77°F).

Protect from excessive heat above 40°C(104°F)

Do not freeze.

Active Ingredient(s)

Micronized Estriol

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Jojoba Seed Oil, Vitamin E, AloeVera, Grape Seed Oil, Camellia Seed Oil,Juice,Soy lsoflavones, Wild Yam Root Extract,Japanese Knotweed Root Extract, Kudzu RootExtract, Black Cohosh Root Extract,Pomegranate Extract, Red Clover Flower Extract,Green Tea Leaf Extract, Ginseng Root Extract, OatExtract, Hyaluronic Acid, Arginine.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact aPoison Control Centerimmediately.(1-800-222-1222)*Avoid contact with eyes.

lf contact occurs, rinse with water.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)