P25 Progesterone Cream: Package Insert and Label Information

P25 PROGESTERONE 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) 2.5%

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.

USES: 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.

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 Herbal-Active® (Natural Preservative) Radish Extract (Natural Preservative) Carbomer Allantoin Shea Butter Sunflower Lecithin Retinol (vitamin A) Sodium Bicarbonate

Questions?

care@biolabspro.com

www.biolabspro.com

P25 PROGESTERONE CREAM progesterone cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82018-0011 Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROGESTERONE (PROGESTERONE) PROGESTERONE 25 mg in 85 g

Inactive Ingredients Ingredient Name Strength GLYCERIN 1 mg in 85 g ALLANTOIN 1 mg in 85 g OLIVE OIL 1 mg in 85 g COCONUT OIL 1 mg in 85 g STEARIC ACID 1 mg in 85 g ISOPROPYL PALMITATE 1 mg in 85 g LECITHIN, SUNFLOWER 1 mg in 85 g SHEA BUTTER 1 mg in 85 g ALOE VERA LEAF 1 mg in 85 g SODIUM BICARBONATE 1 mg in 85 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:82018-0011-5 85 g 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