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Balance Plus Cream

Balance Plus Cream

Approved
Approval ID

37e5e4ae-8cb1-19bb-e063-6294a90ac43d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 1, 2025

Manufacturers
FDA

SHYNE BRANDS/BIOLabs PRO

DUNS: 014926486

Products 1

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

estriol,estradiol,progesterone,dhea

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82018-0028
Product Classification
G
Generic Name
estriol,estradiol,progesterone,dhea
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJune 1, 2025
FDA Product Classification

INGREDIENTS (14)

PROGESTERONEActive
Quantity: 6000 mg in 102 g
Code: 4G7DS2Q64Y
Classification: ACTIB
ALLANTOINInactive
Quantity: 1 mg in 102 g
Code: 344S277G0Z
Classification: IACT
LECITHIN, SUNFLOWERInactive
Quantity: 1 mg in 102 g
Code: 834K0WOS5G
Classification: IACT
ESTRIOLActive
Quantity: 240 mg in 102 g
Code: FB33469R8E
Classification: ACTIB
ESTRADIOLActive
Quantity: 60 mg in 102 g
Code: 4TI98Z838E
Classification: ACTIB
ISOPROPYL PALMITATEInactive
Quantity: 1 mg in 102 g
Code: 8CRQ2TH63M
Classification: IACT
STEARIC ACIDInactive
Quantity: 1 mg in 102 g
Code: 4ELV7Z65AP
Classification: IACT
SHEA BUTTERInactive
Quantity: 1 mg in 102 g
Code: K49155WL9Y
Classification: IACT
ALOE VERA LEAFInactive
Quantity: 1 mg in 102 g
Code: ZY81Z83H0X
Classification: IACT
COCONUT OILInactive
Quantity: 1 mg in 102 g
Code: Q9L0O73W7L
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 1 mg in 102 g
Code: 8MDF5V39QO
Classification: IACT
OLIVE OILInactive
Quantity: 1 mg in 102 g
Code: 6UYK2W1W1E
Classification: IACT
GLYCERINInactive
Quantity: 1 mg in 102 g
Code: PDC6A3C0OX
Classification: IACT
PRASTERONEActive
Quantity: 1000 mg in 102 g
Code: 459AG36T1B
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/1/2025

BalancePlusLabel

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/1/2025

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.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/1/2025

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

LOINC: 55105-1Updated: 6/1/2025

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.

WARNINGS SECTION

LOINC: 34071-1Updated: 6/1/2025

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 - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 6/1/2025

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/1/2025

Keep Out of Reach of Children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/1/2025

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 SECTION

LOINC: 51727-6Updated: 6/1/2025

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)

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/1/2025

Questions?

care@biolabspro.com

www.biolabspro.com

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Balance Plus Cream - FDA Drug Approval Details