Dosage And Use
Apply once or twice a day. Massage into wrists, inner arms, thighs, chest, or use as directed by your physician. Each pump is 5 g of Estriol
Estriol 5000 Mcg 5 G Cream
FDA Label NDC 87250-105
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wise Essentials Llc for the product Estriol 5000 Mcg 5 G (NDC 87250-105). 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 dosage and use, purpose, pregnant or breastfeeding, keep out of reach of children, questions, reference section, estriol 5 g 50000 mcg, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
This is a topical cream that contains bio-identical micronized USP Estriol derived from wild yam, blended moisturizing MSN, Shea Butter, Olive Oil,and Coconut Oil. When applied topically to the skin, it may help to balance your hormones and provide support for perimenopause and menopause
Pregnant Or Breastfeeding
If pregnant or nursing or if you have a serious medical condition, consult a healthcare professional before using this product.
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Questions
Contact [email protected]
www.wiseessentials.com
Reference Section
Medline Plus. Click here https://vsearch.nlm.nih.gov/
Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary
https://clinicaltrials.gov/search?term=ESTRIOL
https://go.drugbank.com/drugs/DB04573
Report Adverse Events click here https://www.accessdata.fda.gov/scripts/medwatch/
FDA Safety Recalls Click here https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Presence in Breast Milk Click here https://www.ncbi.nlm.nih.gov/books/NBK501345/
Report Adverse Events click here https://www.accessdata.fda.gov/scripts/medwatch/</p> <p></p> <p>FDA Safety Recalls Click here https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts</p> <p></p> <p>Presence in Breast Milk Click here https://www.ncbi.nlm.nih.gov/books/NBK501345/</p>
Estriol 5 G 50000 Mcg
Estriol 5 g 50000 mcg
Warnings
If pregnant or nursing or if you have a serious medical condition, consult a healthcare professional before using this product.
Discontinue use if skin irritation or red skin develops, and consult a Physician.
California Prop 65 Law requires this statement: This product contains progesterone, a chemical known only to the State of California to cause cancer.
Cease using this product and seek medical attention if skin irritation or other negative reactions occur.
Inactive Ingredients
Purified Water, Vegetable Glycerin, (Kosher Source), Micronized Estriol USP, Caprylic/Capric Triglyceride, Aloe Vera Gel, Stearic Acid, MSM (Methylsulfonylmethane), Isopropyl Palmitate, Herbs & Blend of Essential Oils (Natural Preservative), Olive Oil, Coconut Oil, Stearyl Alcohol, Shea Butter, Carbopol® Ultrez 10,, Sunflower Lecithin
Indication And Usage Section
USES:
This is a topical cream that contains bio-identical estriol derived from wild yam. When applied to the skin it can help balance your hormones and provide temporary relief from menopausal symptoms such as hot flashes.
DIRECTIONS:
Apply once or twice a day. Massage into inner arms, thighs, chest or apply to inner forearm and rub arms together or use as directed by your Physician.
Estriol Label
* Please review the disclaimer below.
