P50 Progesterone Cream

P50 Progesterone Cream
SPL v4
SPL
SPL Set ID c47121df-6c04-b273-e053-2a95a90aa549
Route
TRANSDERMAL
Published
Effective Date 2021-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

DRUG FACTS Active Ingredients Micronizrd Progesterone USP (Wild Yam) 5%


Medication Information

Warnings and Precautions

WARNING: FOR EXTERNAL COSMETIC USE ONLY. Discontinue use if irritation or red skin develops, and consult a Physician. If pregnant, nursing, or if you have a serious medical condition consult a healthcare professional before using this product. Do not use with any other progesterone or progestins. Do not use if tamper-evident seal is broken or missing. California Prop 65 Law requires this statement: This product contains progesterone, a chemical known only to the State of California to cause cancer. Cease using this product and seek medical attention if skin irritation or other negative reactions occur. 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.

THIS CONTAINER Yields approximately 70 full pumps or 50 mg of bio-identical Progesterone USP (5%) per pump. This is an All Natural product. Application is intended for external cosmetic use.

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) 5%

Section 50565-1

Keep Out of Reach of Children.

Section 51727-6

Purified Water, Glycerin (Plant source - kosher) Aloe Vera Gel, Caprylic/Capric Triglyceride, Stearic Acid, MSM (Methylsulfonylmethane), Olive Oil, Coconut Oil, Isopropyl Palmitate, Stearyl Alcohol, Vitamin E, Blend of Essential oils and herbs (Natural Preservative), Radish Extract (Natural Preservative) Carbomer Allantoin Shea Butter Sunflower Lecithin Sodium Bicarbonate.

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 progesterone derived from wild yam. 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) 5%


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.

THIS CONTAINER Yields approximately 70 full pumps or 50 mg of bio-identical Progesterone USP (5%) per pump. This is an All Natural product. Application is intended for external cosmetic use.

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)

WARNING: FOR EXTERNAL COSMETIC USE ONLY. Discontinue use if irritation or red skin develops, and consult a Physician. If pregnant, nursing, or if you have a serious medical condition consult a healthcare professional before using this product. Do not use with any other progesterone or progestins. Do not use if tamper-evident seal is broken or missing. California Prop 65 Law requires this statement: This product contains progesterone, a chemical known only to the State of California to cause cancer. Cease using this product and seek medical attention if skin irritation or other negative reactions occur. KEEP OUT OF REACH OF CHILDREN.

Section 50565-1 (50565-1)

Keep Out of Reach of Children.

Section 51727-6 (51727-6)

Purified Water, Glycerin (Plant source - kosher) Aloe Vera Gel, Caprylic/Capric Triglyceride, Stearic Acid, MSM (Methylsulfonylmethane), Olive Oil, Coconut Oil, Isopropyl Palmitate, Stearyl Alcohol, Vitamin E, Blend of Essential oils and herbs (Natural Preservative), Radish Extract (Natural Preservative) Carbomer Allantoin Shea Butter Sunflower Lecithin Sodium Bicarbonate.

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 progesterone derived from wild yam. 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) 5%


Advanced Ingredient Data


Raw Label Data

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