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P75 maxx with retinol all natural progesterone 75 cream - Prescription Drug Labeling

Product NDC Code 82018-0013
Drug Name

P75 maxx with retinol all natural progesterone 75 cream

Type Brand
Active Ingredients
Progesterone 1 mg/mg
Route TRANSDERMAL
Dosage Form CREAM
Labeler Name SHYNE BRANDS
Packages
Package NDC Code Description
82018-0013-7 85000 mg in 1 bottle, pump (82018-0013-7)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
DRUG FACTS Active Ingredients Micronizrd Progesterone USP (Wild Yam) 7.5%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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.

Purpose

Information about the drug product’s indications for use.
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.

Spl product data elements

Usually a list of ingredients in a drug product.
P75 Maxx with Retinol All Natural Progesterone 75 Cream P75 Progesterone Cream ALOE VERA LEAF OLIVE OIL COCONUT OIL SODIUM BICARBONATE LECITHIN, SUNFLOWER GLYCERIN ISOPROPYL PALMITATE SHEA BUTTER STEARIC ACID ALLANTOIN PROGESTERONE PROGESTERONE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
P75 Drug Facts Label

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep Out of Reach of Children.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? [email protected] www.biolabspro.com

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or nursing or if you have a serious medical condition consult a healthcare professional before using this product.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API

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