Label: BIEST 2.5 ESTROGEN CREAM- estriol,estradiol cream

  • 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.

  • ACTIVE INGREDIENT

    DRUG FACTS

    Active Ingredients

    Micronizrd Estriol USP (Wild Yam) .2%

    Micronizrd Estradiol USP (Wild Yam) .05%

  • PURPOSE

    This is a topical cream that contains bio-identical estriol and estradiol derived from wild yam and formulated in an 80:20 ratio. When applied to the skin it can help balance your hormones and provide temporary relief from menopausal symptoms such as hot flashes.

  • INDICATIONS & USAGE

    This is a topical cream that contains bio-identical estriol and estradiol derived from wild yam and formulated in an 80:20 ratio. When applied to the skin it can help balance your hormones and provide temporary relief from menopausal symptoms such as hot flashes.

  • WARNINGS

    For external cosmetic use only. If pregnant or nursing, consult a healthcare professional before using this product. Cease using this product and seek medical attention if skin irritation or other negative reactions occur. Do not use if tamper-evident seal is broken or missing. California Prop 65 Law requires this statement:

    This product contains estrogen, a chemical known only to the state of California to cause cancer.

    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, Herbal-Active
    (Natural Preservstive), Radish Extract (Natural
    Preservative), Carbomer, Allantoin, Shea Butter, Sunflower
    Lecithin, Sodium Bicarbonate.

  • QUESTIONS

    Questions?

    care@biolabspro.com

    www.biolabspro.com

  • PRINCIPAL DISPLAY PANEL

    BiEST 2.5 Label

  • INGREDIENTS AND APPEARANCE
    BIEST 2.5 ESTROGEN CREAM 
    estriol,estradiol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82018-0007
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESTRIOL (UNII: FB33469R8E) (ESTRIOL - UNII:FB33469R8E) ESTRIOL2 mg  in 85 g
    ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL0.5 mg  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP) 1 mg  in 85 g
    ALLANTOIN (UNII: 344S277G0Z) 1 mg  in 85 g
    COCONUT OIL (UNII: Q9L0O73W7L) 1 mg  in 85 g
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) 1 mg  in 85 g
    OLIVE OIL (UNII: 6UYK2W1W1E) 1 mg  in 85 g
    SHEA BUTTER (UNII: K49155WL9Y) 1 mg  in 85 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 mg  in 85 g
    GLYCERIN (UNII: PDC6A3C0OX) 1 mg  in 85 g
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) 1 mg  in 85 g
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) 1 mg  in 85 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82018-0007-185 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/15/2021
    Labeler - SHYNE BRANDS (014926486)