BiEST 2.5 Estrogen Cream: Package Insert and Label Information

BIEST 2.5 ESTROGEN CREAM- estriol and estradiol 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.

DRUG FACTS

Active Ingredients

Micronizrd Estriol USP (Wild Yam) .2%

Micronizrd Estradiol USP (Wild Yam) .05%

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.

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.

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.

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

Questions?

care@biolabspro.com

www.biolabspro.com

BIEST 2.5 ESTROGEN CREAM estriol,estradiol cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82018-0007 Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESTRIOL (ESTRIOL) ESTRIOL 2 mg in 85 g ESTRADIOL (ESTRADIOL) ESTRADIOL 0.5 mg in 85 g

Inactive Ingredients Ingredient Name Strength STEARIC ACID 1 mg in 85 g ALLANTOIN 1 mg in 85 g COCONUT OIL 1 mg in 85 g SODIUM BICARBONATE 1 mg in 85 g OLIVE OIL 1 mg in 85 g SHEA BUTTER 1 mg in 85 g ALOE VERA LEAF 1 mg in 85 g GLYCERIN 1 mg in 85 g ISOPROPYL PALMITATE 1 mg in 85 g LECITHIN, SUNFLOWER 1 mg in 85 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:82018-0007-1 85 g in 1 BOTTLE, PUMP None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/15/2021

Labeler — SHYNE BRANDS (014926486)

Revised: 06/2021 SHYNE BRANDS