Label: P75 MAXX WITH RETINOL ALL NATURAL PROGESTERONE 75 CREAM- p75 progesterone cream cream

  • Category: HUMAN OTC DRUG LABEL

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 11, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    DRUG FACTS

    Active Ingredients

    Micronizrd Progesterone USP (Wild Yam) 7.5%

  • PURPOSE

    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.

  • 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 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.

  • 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

    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

    Keep Out of Reach of Children.

  • DOSAGE & ADMINISTRATION

    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.

  • 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 Retinol (vitamin A) Sodium Bicarbonate

  • QUESTIONS

    Questions?

    care@biolabspro.com

    www.biolabspro.com

  • PRINCIPAL DISPLAY PANEL

    P75 Drug Facts Label

  • INGREDIENTS AND APPEARANCE
    P75 MAXX WITH RETINOL ALL NATURAL PROGESTERONE 75 CREAM 
    p75 progesterone cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82018-0013
    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
    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
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) 1 mg  in 1 mg
    GLYCERIN (UNII: PDC6A3C0OX) 1 mg  in 1 mg
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) 1 mg  in 1 mg
    SHEA BUTTER (UNII: K49155WL9Y) 1 mg  in 1 mg
    STEARIC ACID (UNII: 4ELV7Z65AP) 1 mg  in 1 mg
    ALLANTOIN (UNII: 344S277G0Z) 1 mg  in 1 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82018-0013-785000 mg 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)