Otc - Active Ingredient
Estriol 0.2%
Estriol Cream
FDA Label NDC 87278-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangxi Keyun E-commerce Co., Ltd. for the product Estriol Cream (NDC 87278-010). 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 - when using, otc - stop use, otc - 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
Otc - Purpose
Hormone Balance
Indications & Usage
Helps maintain hormonal balance. May help ease symptoms associated with menopause.
Warnings
For external use only
Otc - Do Not Use
Do not use if pregnant, nursing, or trying to conceive.
Otc - When Using
Avoid contact with eyes.
If contact occurs, rinse thoroughly with water.
Otc - Stop Use
If irritation or rash develops, discontinue use and consult a health care provider.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, seek medical help or contact a Poison Control Center immediately.
Dosage & Administration
Take 2 pumps of this product onto your fingertips Apply cream evenly to the intimate area (inner labia and perineal region) Wait for 20 minutes until the cream is fully absorbed. Precautions Target audience: For adult women only.
Inactive Ingredient
Butylene Glycol
Glycerin
Shea Butter
Cetearyl Alcohol
Sunflower Seed Oil
Bisabolol
Tocopheryl Acetate
Lactobacillus Ferment
Dipotassium Glycyrrhizate
Carbomer
Hydroxyphenyl Propamidobenzoic Acid
Xanthan Gum
Magnolia Officinalis (Magnolia) Bark Extract
Sodium Hyaluronate
Portulaca Oleracea (PORTULACA OLERACEA) Extract
Phenoxyethanol
Package Label.Principal Display Panel
Label (Label)
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