OTC Medication Information: P75 Maxx with Retinol All Natural Progesterone 75 Cream

P75 MAXX WITH RETINOL ALL NATURAL PROGESTERONE 75 CREAM- progesterone cream
SHYNE BRANDS

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DRUG FACTS

Active Ingredients

Micronizrd Progesterone USP (Wild Yam) 7.5%

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.

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.

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.

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.

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.

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

Questions?

care@biolabspro.com

www.biolabspro.com

P75 Drug Facts Label
(click image for full-size original)

P75 MAXX WITH RETINOL ALL NATURAL PROGESTERONE 75 CREAM
p75 progesterone cream cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:82018-0013
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROGESTERONE (PROGESTERONE) PROGESTERONE 1 mg in 1 mg
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF 1 mg in 1 mg
OLIVE OIL 1 mg in 1 mg
COCONUT OIL 1 mg in 1 mg
SODIUM BICARBONATE 1 mg in 1 mg
LECITHIN, SUNFLOWER 1 mg in 1 mg
GLYCERIN 1 mg in 1 mg
ISOPROPYL PALMITATE 1 mg in 1 mg
SHEA BUTTER 1 mg in 1 mg
STEARIC ACID 1 mg in 1 mg
ALLANTOIN 1 mg in 1 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82018-0013-7 85000 mg in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/10/2021
Labeler — SHYNE BRANDS (014926486)

Revised: 06/2021 SHYNE BRANDS

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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