Otc - Active Ingredient
Estriol 0.3%
Estriol Cream
FDA Label NDC 84763-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yunqi Cosmetics (shenzhen) Co., Ltd for the product Estriol Cream (NDC 84763-013). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Hormone Support
Indications & Usage
Helps support hormonal balance.
May help ease symptoms associated with menopause.
Warnings
For external use only
Otc - Do Not Use
inside the vagina
in the eyes
on broken skin
Otc - Ask Doctor/Pharmacist
Ask a doctor before use if you have
pregnant.
breast-feeding
trying to conceive
unusual symptoms
persistent irritation
Otc - When Using
When using this product
for external vulvar use only
avoid contact with eyes
do not apply inside the vagina
avoid contact with broken skin
Otc - Stop Use
Stop use and ask a doctor if
irritation worsens or persists
unusual symptoms occur
Otc - Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Apply 2 pumps to fingertips.
Spread evenly over the external vulvar and perineal area.
Do not apply inside the vagina.
Wait about 20 minutes until absorbed.
Wash hands after use.
Inactive Ingredient
Water
Glycerin
Ethylhexyl Palmitate
Caprylic/Capric Triglyceride
Cetearyl Alcohol
Hydrogenated Jojoba Oil
Limnanthes Alba (Meadowfoam) Seed Oil
Dioscorea Villosa (Wild Yam) Root Extract
Betaine
Citric Acid
Sodium Hyaluronate
Hydroxyacetophenone
Phenoxyethanol
Tocopherol
Package Label.Principal Display Panel
Label1 (Label1)
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