Otc - Active Ingredient
DRUG FACTS
Active Ingredients
Micronizrd Estriol USP (Wild Yam) .4%
Micronizrd Estradiol USP (Wild Yam) .1%
Biest 5.0 Estrogen Cream - 3.6oz Cream
FDA Label NDC 82018-0029
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shyne Brands/biolabs Pro for the product Biest 5.0 Estrogen Cream - 3.6oz (NDC 82018-0029). 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 - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
This is a topical cream that contains bio-identical estriol and estradiol derived from wild yam and formulated in an 80:20 ratio. When applied to the skin it can help balance your hormones and provide temporary relief from menopausal symptoms such as hot flashes.
Indications & Usage
USES:
This is a topical cream that contains bio-identical estriol and estradiol derived from wild yam and formulated in an 80:20 ratio. 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.
Warnings
For external cosmetic use only. If pregnant or nursing, consult a healthcare professional before using this product. Cease using this product and seek medical attention if skin irritation or other negative reactions occur. Do not use if tamper-evident seal is broken or missing. California Prop 65 Law requires this statement:
This product contains estrogen, a chemical known only to the state of California to cause cancer.
KEEP OUT OF REACH OF CHILDREN.
Otc - Pregnancy Or Breast Feeding
If pregnant or nursing or if you have a serious medical condition consult a healthcare professional before using this product.
Otc - Keep Out Of Reach Of Children
Keep Out of Reach of Children.
Dosage & Administration
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 you physician.
Inactive Ingredient
Purified Water, Vegetable Glycerin, Aloe Vera Gel,
Caprylic/Capric Triglyceride,Stearic Acid,Olive Oil,
Coconut Oil, Shea Butter, Sunflower Lecithin,
Methylsulfonylmethane (MSM), Stearyl Alcohol,
Isopropyl Palmitate,Allantoin,Carbomer,
Sodium Bicarbonate, Herbal-Active
(Natural Preservstive)
Otc - Questions
Package Label.Principal Display Panel
Biest5_3.6_label (Biest5 3.6 Drugfactslabel)
* Please review the disclaimer below.
