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FDA Approval

Bestmade Natural Products Cimicifuga Racemosa

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Bestmade Natural Products
DUNS: 047124582
Effective Date
May 27, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Black cohosh(30 [hp_C] in 30 [hp_C])

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Total Operations Management LLC DBA: Bestmade Natural Products Micro

Bestmade Natural Products

047124582

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Bestmade Natural Products Cimicifuga Racemosa

Product Details

NDC Product Code
82969-5041
Route of Administration
ORAL
Effective Date
May 27, 2025
Code: K73E24S6X9Class: ACTIBQuantity: 30 [hp_C] in 30 [hp_C]
LACTOSEInactive
Code: J2B2A4N98GClass: IACTQuantity: 30 [hp_C] in 30 [hp_C]
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 30 [hp_C] in 30 [hp_C]

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Entire package label

cimicifuga


INDICATIONS & USAGE SECTION

Uses

Temporarily relieves occasional painful menstrual periods, joint discomfort, and uterine cramps.*

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.
This product is not intended to diagnose, treat, cure, or prevent any disease.

DOSAGE & ADMINISTRATION SECTION

How to Use

Take with water 3-4 times a day.

Ages 12 or older, 5 Pellets, Ages 12-2, 3 Pellets, Ages below 2, consult your Doctor.


WARNINGS SECTION

Warnings and Storage:
Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.
Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.
This product is not intended to diagnose, treat, cure, or prevent any disease.


OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Cimicifuga Racemosa (Black Cohosh) [HPUS] 30c potency

OTC - PURPOSE SECTION

Uses

Temporarily relieves occasional painful menstrual periods, joint discomfort, and uterine cramps.*

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.
This product is not intended to diagnose, treat, cure, or prevent any disease.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings and Storage:
Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.
Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.


INACTIVE INGREDIENT SECTION

Ingredients

Inactive: Sucrose/Lactose Pellets base to Preserve Remedy


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