Otc - Active Ingredient
Estriol 0.2%
Estriol Cream
FDA Label NDC 87704-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Yunzhen Trading Co., Ltd. for the product Estriol Cream (NDC 87704-001). 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
For Women's Menopause Support
Indications & Usage
Helps maintain hormonal balance and may ease symptoms associated with menopause.
Warnings
For external use only
Otc - Do Not Use
1.Do not use if you arepregnant or breastfeeding.
2.Do not use if you haveundiagnosed vaginal bleeding.
3.Do not exceed the recommended dosage.
Otc - When Using
4.Avoid contact with eyes.
Women at all stages of menopause.
Otc - Stop Use
5.lf any other health issues occur, discontinue use and consult a doctor immediately.
Otc - Keep Out Of Reach Of Children
6.lf swallowed, seek medical help or contact a Poison Control Center immediately.
Dosage & Administration
1.Apply twice daily. Dispense
2 pumps of cream onto clean fingers, then spread evenlyover the labia and perineal area (extemal use only).
2.For best results, apply after bathing while lying down,and allow 20 minutes for the cream to absorb before resuming normal activities.
Inactive Ingredient
AQUA
GLYERIN
PANTHENOL
1,2-HEXANEDIOL
CARBOMER HOMOPOLYMER
ARGININE
Package Label.Principal Display Panel
Label1 (Label1)
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