Balance Plus Cream
Balance Plus Cream
37e5e4ae-8cb1-19bb-e063-6294a90ac43d
HUMAN OTC DRUG LABEL
Jun 1, 2025
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
Product Classification
Product Specifications
INGREDIENTS (14)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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.
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.
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 - 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep Out of Reach of Children.
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.
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)
OTC - QUESTIONS SECTION
Questions?
care@biolabspro.com
www.biolabspro.com