P50 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.

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P50 Progesterone Cream

DRUG FACTS

Active Ingredients

Micronizrd Progesterone USP (Wild Yam) 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 50 mg of bio-identical Progesterone USP (5%) per pump. 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 Sodium Bicarbonate.

Questions?

care@biolabspro.com

www.biolabspro.com

P50 Drug Facts Label

P50 PROGESTERONE CREAM 
progesterone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82018-0012
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE1 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z) 1 mg  in 1 mg
GLYCERIN (UNII: PDC6A3C0OX) 1 mg  in 1 mg
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) 1 mg  in 1 mg
STEARIC ACID (UNII: 4ELV7Z65AP) 1 mg  in 1 mg
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) 1 mg  in 1 mg
SHEA BUTTER (UNII: K49155WL9Y) 1 mg  in 1 mg
ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 mg  in 1 mg
OLIVE OIL (UNII: 6UYK2W1W1E) 1 mg  in 1 mg
COCONUT OIL (UNII: Q9L0O73W7L) 1 mg  in 1 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 1 mg  in 1 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82018-0012-685000 mg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/14/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/14/2021
Labeler - SHYNE BRANDS (014926486)

Revised: 6/2021
Document Id: c5533eb0-5f6b-729b-e053-2995a90aa88f
Set id: c47121df-6c04-b273-e053-2a95a90aa549
Version: 3
Effective Time: 20210621
 
SHYNE BRANDS