Balance Plus Cream

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

BIOLabs PRO

DUNS Number

014926486

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

82018-0028

Route of Administration

TRANSDERMAL

Effective Date

June 1, 2025

Ingredients

ProgesteroneActive

Code: 4G7DS2Q64YClass: ACTIBQuantity: 6000 mg in 102 g

ALLANTOINInactive

Code: 344S277G0ZClass: IACTQuantity: 1 mg in 102 g

LECITHIN, SUNFLOWERInactive

Code: 834K0WOS5GClass: IACTQuantity: 1 mg in 102 g

EstriolActive

Code: FB33469R8EClass: ACTIBQuantity: 240 mg in 102 g

EstradiolActive

Code: 4TI98Z838EClass: ACTIBQuantity: 60 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

PrasteroneActive

Code: 459AG36T1BClass: ACTIBQuantity: 1000 mg in 102 g

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BalancePlusLabel

INDICATIONS & USAGE SECTION

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 and progesterone, 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 Progesterone USP (Wild Yam) 6%

Micronizrd Estriol USP (Wild Yam) 1%

Micronizrd Estradiol USP (Wild Yam) .24%

Micronizrd Dhea USP (Wild Yam) .06%

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 along with progesterone, dhea, and Vitamin D3 paired with K2. 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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Balance Plus Cream

FDA Approval Summary

Registrants1

BIOLabs PRO

Products1