Otc - Active Ingredient
Active Ingredient (per 1g)
Progesterone USP 21.3% .......... Hormone Support
Progest-oil-1oz-sb Oil
FDA Label NDC 82018-0026
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 Progest-oil-1oz-sb (NDC 82018-0026). 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
Helps support hormone balance.
Indications & Usage
May provide temporary relief from menopausal symptoms such as hot flashes, mood swings and night sweats.
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 progesterone, 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, consult a healthcare professional before using this product.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Dosage & Administration
Apply 5-10 drops (40-80mg progesterone) to inner arms, thighs, chest or apply to inner forearm and rub arms together or use as directed by your Physician.
Inactive Ingredient
MCT Oil, Vitamin E
Otc - Questions
Questions?
[email protected]
www.biolabspro.com
Package Label.Principal Display Panel
Progesterone Oil 1oz (Progestoil 1oz Drugfactslabel)
* Please review the disclaimer below.
