Label: P50 PROGESTERONE CREAM- progesterone cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 82018-0012-6 - Packager: SHYNE BRANDS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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 Label Information
Updated June 21, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
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.
-
WARNINGS
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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
-
INACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
P50 PROGESTERONE CREAM
progesterone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82018-0012 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE 1 mg in 1 mg Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82018-0012-6 85000 mg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/14/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/14/2021 Labeler - SHYNE BRANDS (014926486)
