Initial Drug Listing - Vigority Estriol Cream

Initial Drug Listing - Vigority Estriol Cream
SPL v1
SPL
SPL Set ID 3b2b02fb-5806-f847-e063-6394a90aa63c
Route
TOPICAL
Published
Effective Date 2025-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Estriol (3 mg)
Inactive Ingredients
Glycerin Pueraria Montana Var. Lobata Root Camellia Oil Grape Seed Oil Pomegranate Seed Oil Green Tea Leaf Hyaluronic Acid Arginine Tocopherol Jojoba Oil Black Cohosh Dioscorea Oppositifolia (wild Yam) Root Aloe Vera Leaf Juice Reynoutria Japonica Root Red Clover Avena Sativa Whole Panax Ginseng Root Water Soy Isoflavones

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-15

Description

Micronized Estriol USP 0.3%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • Helps improve skin tone and texture associated with estrogen decline
  • Supports hydration, firmness, and elasticity in aging skin
  • Helps relieve menopausal discomforts
Dosage and Administration
  • apply 1 pump daily to the face, neck, chest, inner thighs or arms
  • message gently until fully absorbed
Description

Micronized Estriol USP 0.3%

Section 50565-1

Keep out of reach of children

Section 50566-9

if rash or irritation occurs

Section 50567-7

keep out of eyes.

Section 50569-3

If pregnant, nursing, or undergoing hormone-related treatment, consult a qualified healthcare professional before use.

Section 50570-1

on broken or irritated skin

Section 51727-6

Water, Glycerin, Grape Seed Oil, Jojoba Seed Oil, Camellia Seed Oil, Vitamin E, Aloe Vera Juice, Soy Isoflavones, Wild Yam Root Extract, Japanese Knotweed Root Extract, Kudzu Root Extract, Black Cohosh Root Extract, Pomegranate Extract, Red Clover Flower Extract, Green Tea Leaf Extract, Ginseng Root Extract, Oat Extract, Hyaluronic Acid, Arginine

Section 51945-4

Section 53413-1
Section 55105-1

Hormonal Skin Support

Section 55106-9

Micronized Estriol USP 0.3%

Section 60561-8

Protect the product in this container from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)
  • Helps improve skin tone and texture associated with estrogen decline
  • Supports hydration, firmness, and elasticity in aging skin
  • Helps relieve menopausal discomforts
Dosage and Administration (34068-7)
  • apply 1 pump daily to the face, neck, chest, inner thighs or arms
  • message gently until fully absorbed
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

if rash or irritation occurs

Section 50567-7 (50567-7)

keep out of eyes.

Section 50569-3 (50569-3)

If pregnant, nursing, or undergoing hormone-related treatment, consult a qualified healthcare professional before use.

Section 50570-1 (50570-1)

on broken or irritated skin

Section 51727-6 (51727-6)

Water, Glycerin, Grape Seed Oil, Jojoba Seed Oil, Camellia Seed Oil, Vitamin E, Aloe Vera Juice, Soy Isoflavones, Wild Yam Root Extract, Japanese Knotweed Root Extract, Kudzu Root Extract, Black Cohosh Root Extract, Pomegranate Extract, Red Clover Flower Extract, Green Tea Leaf Extract, Ginseng Root Extract, Oat Extract, Hyaluronic Acid, Arginine

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
Section 55105-1 (55105-1)

Hormonal Skin Support

Section 55106-9 (55106-9)

Micronized Estriol USP 0.3%

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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