Otc - Active Ingredient
Estradiol 0.2%
Estriol Cream
FDA Label NDC 87255-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Mengyue Technology Co., Ltd. for the product Estriol (NDC 87255-006). 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 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 suppor
Indications & Usage
Uses
Helps support hormonal balance. May help ease symptoms associated with menopause.
Warnings
Warnings
For external use only. Do not use if pregnant, nursing. or trying to conceive. Avoid contact with eyes. If contact occurs,rinse thoroughly with water. If irritation or rash develops, discontinue use and consult a healthcare provider.Keep out of reachof children. If swallowed, get medical help or contact a Poison Control Center immediately.
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 healthcare provider.
Otc - Keep Out Of Reach Of Children
Keep out of reachof children.
Dosage & Administration
Directions
Massage into the inner arm, thighs,ochest,or apply to the inner forearm and rub arms together until absorbed Apply two pumps in the morning and two in the afternoon or evening, or as directed by a healthcare provider.
Storage And Handling
CoreStorage
Conditions
Cool. Dry Environment: The product should be stored at room temperature (ideally between 15-25℃ / 59-77°F). in a dry place.and away from direct sunlight.High temperatures and direct sunlight can accelerate the oxidation and breakdown of active ingredients. leading to reduced effectiveness or changes in consistency (e.g.. the cream may become thinner or separate).
Other information
Store in a cool, dry place. Do not use if seal is broken or missing.
"These slalemenis have not been evalualed by the Food and Drug Adiministration, This product is not intended to diagnose, treat, cure. or prevent any disease."
Inactive Ingredient
Inactive ingredients
Purified Water, Peach extract.Vegetable Glycerin, Aloe Vera Leaf Gel,Caprylic/Capric Triglyceride.Stearic Acid, Micronized Estriol USP Micronized Estradiol USP Olive Oil.Coconut Oil. Shea Butter, Sunflower Lecithin.Methylsulfonyimethane (MSM). Stearyl Alcohol, Isopropyl Palmitate.Allantoin,Carbomer, Sodium Bicarbonate.
Package Label.Principal Display Panel
87255-006-01 (87255 006 01)
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