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.

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P25 Progesterone Cream

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 Drug Facts Label

P25 PROGESTERONE CREAM 
progesterone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82018-0011
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE25 mg  in 85 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1 mg  in 85 g
ALLANTOIN (UNII: 344S277G0Z) 1 mg  in 85 g
OLIVE OIL (UNII: 6UYK2W1W1E) 1 mg  in 85 g
COCONUT OIL (UNII: Q9L0O73W7L) 1 mg  in 85 g
STEARIC ACID (UNII: 4ELV7Z65AP) 1 mg  in 85 g
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) 1 mg  in 85 g
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) 1 mg  in 85 g
SHEA BUTTER (UNII: K49155WL9Y) 1 mg  in 85 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 mg  in 85 g
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 1 mg  in 85 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82018-0011-585 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/10/2021
Labeler - SHYNE BRANDS (014926486)

Revised: 6/2021
Document Id: c54f027e-b866-4afb-e053-2a95a90a83e1
Set id: c47169b7-1b6a-2ad0-e053-2995a90a0b19
Version: 3
Effective Time: 20210621
 
SHYNE BRANDS