SPL v5
SPL
SPL Set ID 386c357d-97ff-8150-e063-6394a90a2ac8
Route
TOPICAL
Published
Effective Date 2025-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Estriol (4 mg) Estradiol (1 mg)
Inactive Ingredients
Glycerin Shea Butter Sodium Bicarbonate Olive Oil Aloe Vera Leaf Isopropyl Palmitate Allantoin Lecithin, Sunflower Stearic Acid Coconut Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-03-01

Description

DRUG FACTS Active Ingredients Micronized Estriol USP (Wild Yam) .4% Micronized Estradiol USP (Wild Yam) .1%


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, a chemical known only to the state of California to cause cancer.

KEEP OUT OF REACH OF CHILDREN.

Indications and Usage

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 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 Micronized Estriol USP (Wild Yam) .4% Micronized Estradiol USP (Wild Yam) .1%

Section 42228-7

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

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
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. 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

Micronized Estriol USP (Wild Yam) .4%

Micronized Estradiol USP (Wild Yam) .1%


Structured Label Content

Indications and Usage (34067-9)

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 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, a chemical known only to the state of California to cause cancer.

KEEP OUT OF REACH OF CHILDREN.

Section 42228-7 (42228-7)

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

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)
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. 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

Micronized Estriol USP (Wild Yam) .4%

Micronized Estradiol USP (Wild Yam) .1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)