Otc - Active Ingredient
DRUG FACTS
Active Ingredients
Micronizrd Progesterone USP (Wild Yam) 7.5%
P75 Maxx With Retinol All Natural Progesterone 75 Cream
FDA Label NDC 82018-0013
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 for the product P75 Maxx With Retinol All Natural Progesterone 75 Cream (NDC 82018-0013). 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 progesterone 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.
Indications & Usage
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.
THIS CONTAINER Yields approximately 70 full pumps or 75 mg of bio-identical Progesterone USP (7.5%) per pump. It also contains Retinol, Vitamin E, Coconut Oil, Shea Butter, and other ingredients to support transdermal bioavailability and overall skin tone. This is an All Natural product. Application is intended for external cosmetic use.
Warnings
WARNING: FOR EXTERNAL COSMETIC USE ONLY. Discontinue use if irritation or red skin develops, and consult a Physician. If pregnant, nursing, or if you have a serious medical condition consult a healthcare professional before using this product. Do not use with any other progesterone or progestins. 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. Cease using this product and seek medical attention if skin irritation or other negative reactions occur. 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 Glycerin (Plant source - kosher) Aloe Vera Gel Caprylic/Capric Triglyceride Stearic Acid MSM (Methylsulfonylmethane) Olive Oil Coconut Oil Isopropyl Palmitate Stearyl Alcohol Vitamin E Blend of Essential oils and herbs (Natural Preservative) Radish Extract (Natural Preservative) Carbomer Allantoin Shea Butter Sunflower Lecithin Retinol (vitamin A) Sodium Bicarbonate
Otc - Questions
Package Label.Principal Display Panel
P75 Drug Facts Label (B0777x3j6b P75 Drugfactslabel)
* Please review the disclaimer below.
