Balance Plus Cream

Balance Plus Cream
SPL v1
SPL
SPL Set ID 37e5e4ae-8cb1-19bb-e063-6294a90ac43d
Route
TRANSDERMAL
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Progesterone (6000 mg) Estriol (1 mg) Estradiol (240 mg) Prasterone (60 mg)
Inactive Ingredients
Allantoin Lecithin, Sunflower Isopropyl Palmitate Stearic Acid Shea Butter Aloe Vera Leaf Coconut Oil Sodium Bicarbonate Olive Oil Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-06-01

Description

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%


Medication Information

Warnings and Precautions

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.

Indications and Usage

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 and Administration

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.

Description

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%

Section 50565-1

Keep Out of Reach of Children.

Section 51727-6

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)

Section 51945-4

Section 53413-1

Questions?

[email protected]

www.biolabspro.com

Section 53414-9

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

Section 55105-1

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.

Section 55106-9

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%


Structured Label Content

Indications and Usage (34067-9)

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 and Administration (34068-7)

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 and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep Out of Reach of Children.

Section 51727-6 (51727-6)

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)

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

[email protected]

www.biolabspro.com

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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.

Section 55106-9 (55106-9)

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%


Advanced Ingredient Data


Raw Label Data

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