Fermarone 20

Fermarone 20
SPL v1
SPL
SPL Set ID 44ea74ce-2ba1-e578-e063-6394a90ab72d
Route
TRANSDERMAL
Published
Effective Date 2025-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Progesterone (2.5 mg)
Inactive Ingredients
Chaste Tree Fruit Cocos Nucifera (coconut) Oil Jojoba Oil Glycerin Sorbitan Olivate Dioscorea Villosa Tuber Allantoin Radish

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-12-05

Description

Femarone 20 DRUG FACTS Active Ingredient Micronized Progesterone USP (Wild Yam 2%) Uses This topical cream contains USP progesterone derived from wild yam. Applied to the skin may help balance your hormones and provide support for peri-menopause and menopause symptoms. 20 mg per p1/4 tsp of USP progesterone. Inactive Ingredients: Water, Dioscorea Villosa Extract (Wild Yam), Vitex Agnus-Castus, Organic Cocos Nucifera (Coconut Oil*, Organic Vegetable Glycerin*, Emulsifying Wax NF, Olive M 1000, Glyceryl Stearate, Radish Root Extract*, Organic Aloe Barbadensis Leaf (Aloe Vera)*, Allantoin, Xanthan Gum, Organic Jojoba Oil*, Organic Shea Butter*, Made with organic Ingredients Warnings: For external cosmetic use only. Always consult your healthcare provider before using. Cease use and seek medical attention if skin irritation you or any negative reaction. If pregnant or nursing, consult a healthcare professional before use. California Prop 65 Law requires this statement. This product contains progesterone, a chemical known only to the State of California to cause cancer. Keep out of reach of children Store in a cold, dry place Directions: Use twice daily. Massage into inner arms, wrist, chest, or thighs or as directed by your Physician. Questions? [email protected] Wise Essentials, St. Paul, MN 55116 www.WiseEssentials.com MADE IN Distributed and Manufactured in a certified Kosher and FDA registered facility for Wise Essentials St. Paul, MN 55116 Visit us at: www.WiseEssentials.com

Indications and Usage

USES: This is a topical cream that contains bio-identical micronized USP progesterone derived from wild yam, blended with phytoestrogens. When applied topically to the skin, it may help to balance your hormones and also to provide support for perimenopause and menopause. Apply once or twice a day. Massage into wrists, inner arms, thighs, chest, or apply or use as directed by your physician.

Purpose

This is a topical cream that contains bio-identical micronized USP progesterone derived from wild yam, blended with phytoestrogens. When applied topically to the skin, it may help to balance your hormones, and also to provide support for peri menopause and menopausal symptoms.


Medication Information

Warnings and Precautions

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

KEEP OUT OF REACH OF CHILDREN Store in a cool, dry place

Always consult your healthcare provider before using or if pregnant or nursing. Cease use and seek medical attention if skin irritation or a negative reaction.

Keep out of reach of children. Store in a cool, dry place.

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.

Indications and Usage

USES: This is a topical cream that contains bio-identical micronized USP progesterone derived from wild yam, blended with phytoestrogens. When applied topically to the skin, it may help to balance your hormones and also to provide support for perimenopause and menopause.

Apply once or twice a day. Massage into wrists, inner arms, thighs, chest, or apply or use as directed by your physician.

Purpose

This is a topical cream that contains bio-identical micronized USP progesterone derived from wild yam, blended with phytoestrogens. When applied topically to the skin, it may help to balance your hormones, and also to provide support for peri menopause and menopausal symptoms.

Description

Femarone 20 DRUG FACTS Active Ingredient Micronized Progesterone USP (Wild Yam 2%) Uses This topical cream contains USP progesterone derived from wild yam. Applied to the skin may help balance your hormones and provide support for peri-menopause and menopause symptoms. 20 mg per p1/4 tsp of USP progesterone. Inactive Ingredients: Water, Dioscorea Villosa Extract (Wild Yam), Vitex Agnus-Castus, Organic Cocos Nucifera (Coconut Oil*, Organic Vegetable Glycerin*, Emulsifying Wax NF, Olive M 1000, Glyceryl Stearate, Radish Root Extract*, Organic Aloe Barbadensis Leaf (Aloe Vera)*, Allantoin, Xanthan Gum, Organic Jojoba Oil*, Organic Shea Butter*, Made with organic Ingredients Warnings: For external cosmetic use only. Always consult your healthcare provider before using. Cease use and seek medical attention if skin irritation you or any negative reaction. If pregnant or nursing, consult a healthcare professional before use. California Prop 65 Law requires this statement. This product contains progesterone, a chemical known only to the State of California to cause cancer. Keep out of reach of children Store in a cold, dry place Directions: Use twice daily. Massage into inner arms, wrist, chest, or thighs or as directed by your Physician. Questions? [email protected] Wise Essentials, St. Paul, MN 55116 www.WiseEssentials.com MADE IN Distributed and Manufactured in a certified Kosher and FDA registered facility for Wise Essentials St. Paul, MN 55116 Visit us at: www.WiseEssentials.com

Safety

Report Adverse Events click here https://www.accessdata.fda.gov/scripts/medwatch/

FDA Safety Recalls Click here https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Presence in Breast Milk Click here https://www.ncbi.nlm.nih.gov/books/NBK501345/

Section 43683-2

Femarone 20

DRUG FACTS Active Ingredient

Micronized Progesterone USP (Wild Yam 2%)

Uses This topical cream contains USP progesterone derived from wild yam. Applied to the skin may help balance your hormones and provide support for peri-menopause and menopause symptoms.

20 mg per p1/4 tsp of USP progesterone.

Inactive Ingredients:

Water, Dioscorea Villosa Extract (Wild Yam), Vitex Agnus-Castus, Organic Cocos Nucifera (Coconut Oil*, Organic Vegetable Glycerin*, Emulsifying Wax NF, Olive M 1000, Glyceryl Stearate, Radish Root Extract*, Organic Aloe Barbadensis Leaf (Aloe Vera)*, Allantoin, Xanthan Gum, Organic Jojoba Oil*, Organic Shea Butter*, Made with organic Ingredients

Warnings: For external cosmetic use only. Always consult your healthcare provider before using. Cease use and seek medical attention if skin irritation you or any negative reaction. If pregnant or nursing, consult a healthcare professional before use.

California Prop 65 Law requires this statement. This product contains progesterone, a chemical known only to the State of California to cause cancer.

Keep out of reach of children

Store in a cold, dry place

Directions: Use twice daily. Massage into inner arms, wrist, chest, or thighs or as directed by your Physician.

Questions? [email protected]

Wise Essentials, St. Paul, MN 55116

www.WiseEssentials.com

MADE IN

Distributed and Manufactured in a certified

Kosher and FDA registered facility for

Wise Essentials St. Paul, MN 55116

Visit us at: www.WiseEssentials.com

Section 51945-4

Disclaimer

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs For further information about unapproved drugs, https://www.fda.gov/drugs/enforcement-activities-fda/unapproved-drugs

Questions?

QUESTIONS?

Contact [email protected]

Active Ingredient

Micronized Progesterone USP, (Wild Yam) 2%

Related Resources
Inactive Ingredient

Water, Wild Yam Extract, Chaste Tree Berry, Coconut Oil Organic, Vegetable Glycerin USP, Emulsifying Wax NF, Olivem 1000, Glyceryl Stearate, Radish Root Extract, Aloe Vera Powder Organic, Jojoba Oil Organic, Allantoin, Shea Butter Organic

Dosage & Administration

Apply once or twice a day. Massage into wrists, inner arms, thighs, chest, or apply to together or use as directed by your physician.

Pregnancy Or Breastfeeding

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

Keep Out of Reach of Children

Keep out of Reach of Children.


Structured Label Content

Safety (SAFETY)

Report Adverse Events click here https://www.accessdata.fda.gov/scripts/medwatch/

FDA Safety Recalls Click here https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Presence in Breast Milk Click here https://www.ncbi.nlm.nih.gov/books/NBK501345/

Warnings and Precautions (34071-1)

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

KEEP OUT OF REACH OF CHILDREN Store in a cool, dry place

Always consult your healthcare provider before using or if pregnant or nursing. Cease use and seek medical attention if skin irritation or a negative reaction.

Keep out of reach of children. Store in a cool, dry place.

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.

Section 43683-2 (43683-2)

Femarone 20

DRUG FACTS Active Ingredient

Micronized Progesterone USP (Wild Yam 2%)

Uses This topical cream contains USP progesterone derived from wild yam. Applied to the skin may help balance your hormones and provide support for peri-menopause and menopause symptoms.

20 mg per p1/4 tsp of USP progesterone.

Inactive Ingredients:

Water, Dioscorea Villosa Extract (Wild Yam), Vitex Agnus-Castus, Organic Cocos Nucifera (Coconut Oil*, Organic Vegetable Glycerin*, Emulsifying Wax NF, Olive M 1000, Glyceryl Stearate, Radish Root Extract*, Organic Aloe Barbadensis Leaf (Aloe Vera)*, Allantoin, Xanthan Gum, Organic Jojoba Oil*, Organic Shea Butter*, Made with organic Ingredients

Warnings: For external cosmetic use only. Always consult your healthcare provider before using. Cease use and seek medical attention if skin irritation you or any negative reaction. If pregnant or nursing, consult a healthcare professional before use.

California Prop 65 Law requires this statement. This product contains progesterone, a chemical known only to the State of California to cause cancer.

Keep out of reach of children

Store in a cold, dry place

Directions: Use twice daily. Massage into inner arms, wrist, chest, or thighs or as directed by your Physician.

Questions? [email protected]

Wise Essentials, St. Paul, MN 55116

www.WiseEssentials.com

MADE IN

Distributed and Manufactured in a certified

Kosher and FDA registered facility for

Wise Essentials St. Paul, MN 55116

Visit us at: www.WiseEssentials.com

Section 51945-4 (51945-4)

Purpose (PURPOSE)

This is a topical cream that contains bio-identical micronized USP progesterone derived from wild yam, blended with phytoestrogens. When applied topically to the skin, it may help to balance your hormones, and also to provide support for peri menopause and menopausal symptoms.

Disclaimer (DISCLAIMER)

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs For further information about unapproved drugs, https://www.fda.gov/drugs/enforcement-activities-fda/unapproved-drugs

Questions? (QUESTIONS?)

QUESTIONS?

Contact [email protected]

Active Ingredient

Micronized Progesterone USP, (Wild Yam) 2%

Related Resources (RELATED RESOURCES)
Inactive Ingredient (INACTIVE INGREDIENT)

Water, Wild Yam Extract, Chaste Tree Berry, Coconut Oil Organic, Vegetable Glycerin USP, Emulsifying Wax NF, Olivem 1000, Glyceryl Stearate, Radish Root Extract, Aloe Vera Powder Organic, Jojoba Oil Organic, Allantoin, Shea Butter Organic

Indications and Usage (INDICATIONS AND USAGE)

USES: This is a topical cream that contains bio-identical micronized USP progesterone derived from wild yam, blended with phytoestrogens. When applied topically to the skin, it may help to balance your hormones and also to provide support for perimenopause and menopause.

Apply once or twice a day. Massage into wrists, inner arms, thighs, chest, or apply or use as directed by your physician.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Apply once or twice a day. Massage into wrists, inner arms, thighs, chest, or apply to together or use as directed by your physician.

Pregnancy Or Breastfeeding (PREGNANCY OR BREASTFEEDING)

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

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of Reach of Children.


Advanced Ingredient Data


Raw Label Data

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