Active Ingredient(S)
Micronized Estriol
Jardient Estriol Cream
FDA Label NDC 85646-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Glowvera for the product Jardient Estriol Cream (NDC 85646-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, do not use, ask doctor, stop use, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Hormonal Skin Support
Use
Helps improve skin tone and texture associated with estrogen decline . Supports hydration, firmness, and elasticity in aging skin , Helps relieve menopausal discomforts
Warnings
For external use only.
Do Not Use
On damaged or broken skin (cuts, abrasions ，eczema, or burns).
lfyou have known sensitivity to hormonal or estrogenic ingredients.
Ask Doctor
lf you are pregnant, breastfeeding, or takinghormone therapy.’lf you have a history ofhormone-sensitive conditions or cancers.
Stop Use
if irritation occurs.
if an allergic reaction occurs
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.
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.
Other Information
Store at 20° to 25°C(68° to 77°F).
Protect from excessive heat above 40°C(104°F)
Do not freeze.
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
Image
Iamge (Jardient)
* Please review the disclaimer below.
