MedPath
FDA Approval

3.6oz BiEST 2.5 Estrogen Cream

SHYNE BRANDS/BIOLabs PRO (DUNS: 014926486)

June 1, 2025

HUMAN OTC DRUG LABEL

Estriol(2 mg in 102 g)
Estradiol(0.5 mg in 102 g)

Registrants (1)

BIOLabs PRO

014926486

Products (1)

3.6oz BiEST 2.5 Estrogen Cream

82018-0030

TRANSDERMAL

June 1, 2025

ALLANTOINInactive
Code: 344S277G0ZClass: IACTQuantity: 1 mg in 102 g
LECITHIN, SUNFLOWERInactive
Code: 834K0WOS5GClass: IACTQuantity: 1 mg in 102 g
EstriolActive
Code: FB33469R8EClass: ACTIBQuantity: 2 mg in 102 g
EstradiolActive
Code: 4TI98Z838EClass: ACTIBQuantity: 0.5 mg in 102 g
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63MClass: IACTQuantity: 1 mg in 102 g
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACTQuantity: 1 mg in 102 g
SHEA BUTTERInactive
Code: K49155WL9YClass: IACTQuantity: 1 mg in 102 g
ALOE VERA LEAFInactive
Code: ZY81Z83H0XClass: IACTQuantity: 1 mg in 102 g
COCONUT OILInactive
Code: Q9L0O73W7LClass: IACTQuantity: 1 mg in 102 g
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 1 mg in 102 g
OLIVE OILInactive
Code: 6UYK2W1W1EClass: IACTQuantity: 1 mg in 102 g
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 1 mg in 102 g

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biest2.5_3.6_Label


INDICATIONS & USAGE SECTION

USES:

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.

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.

DOSAGE & ADMINISTRATION SECTION

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.


WARNINGS SECTION

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.


OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS

Active Ingredients

Micronizrd Estriol USP (Wild Yam) .2%

Micronizrd Estradiol USP (Wild Yam) .05%

OTC - PURPOSE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children.

OTC - QUESTIONS SECTION

Questions?

care@biolabspro.com

www.biolabspro.com

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or nursing or if you have a serious medical condition consult a healthcare professional before using this product.


INACTIVE INGREDIENT SECTION

Purified Water, Vegetable Glycerin, Aloe Vera Gel,
Caprylic/Capric Triglyceride,Stearic Acid,Olive Oil,
Coconut Oil, Shea Butter, Sunflower Lecithin,
Methylsulfonylmethane (MSM), Stearyl Alcohol,
Isopropyl Palmitate,Allantoin,Carbomer,
Sodium Bicarbonate, Herbal-Active
(Natural Preservstive)


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