FDA.reportPublic FDA data

Menopause Relief Homeopathic Remedy

Manufacturer
Homeocare Laboratories Inc.
Effective date
2015-12-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:19

Label at a glance#

ProductMenopause Relief Homeopathic Remedy
Active ingredientSANGUINARIA CANADENSIS ROOT, STRYCHNOS IGNATII SEED, LACHESIS MUTA WHOLE, DIOSCOREA VILLOSA ROOT, ACTAEA CIMICIFUGA ROOT, CHAMAELIRIUM LUTEUM ROOT, SEPIA ESCULENTA WHOLE, SUS SCROFA OVARY
Label structure10 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

PURPOSE

Relieves Menopausal Symptoms

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

Dioscorea villosa
Cimicifuga racemosa
Sanguinaria Canadensis
Ignatia amara
Helonias dioica
Sepia
Oophorinum
Lachesis

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

Avocado Oil
Caprylyl Glycol
Cetyl Alcohol
Dimethicone
Dimethyl Taurate Copolymer
Glycerin USP
Glyceryl Stearate
Hexylene Glycol
Phenoxyethanol
Polyethylene
Sodium Polyacrylate
Potassium Sorbate
Purified Water
Sodium Acrylate/Sodium Acryloyl
Sunflower Oil
Caprylic/Capric Triglyceride

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

If swallowed, get meical help or contact a poison control center right away.

OTC - QUESTIONS SECTION

QUESTIONS?

(877) 208-1555

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

Rub a pea-sied amount on the underside of your wrist two (2) times a day for as long as you have symptoms.

OTC - DO NOT USE SECTION

DO NOT USE

In eyes, or on broken skin

If pregnant or breastfeeding, ask a health professional before use.

WARNINGS SECTION

WARNINGS

For external use only

INDICATIONS & USAGE SECTION

USES

Relieves menopausal symptoms

Hot flashes, night sweats, headaches

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61727-054-022022-01-28C16284748780-1d6a99b39-6829-a426-e053-dadaa90af4c228229d92-68bc-3781-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61727-054-02Menopause Relief Homeopathic Remedy60 mL in 1 BOTTLECREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61727-054MENOPAUSE RELIEF HOMEOPATHIC REMEDY (SEPIA) CREAM [HOMEOCARE LABORATORIES INC.]1Legacy NDC, 1 package rows20160106_28229d92-68bc-3781-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61727-05461727-054-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
LACHESIS MUTA WHOLE6Y582I290CACTIB
2,4-DIAMINO-5-METHYLPHENOXYETHANOL HYDROCHLORIDEZ28JS1XMY2IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
POLYETHYLENE OXIDE 1000000HZ58M6D839IACT
WATER059QF0KO0RIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
DIOSCOREA VILLOSA ROOTIWY3IWX2G8ACTIB
ACTAEA CIMICIFUGA ROOT65J267BAZTACTIB
CHAMAELIRIUM LUTEUM ROOTDQV54Y5H3UACTIB
SEPIA ESCULENTA WHOLE6ET21QP634ACTIB
SUS SCROFA OVARYS7YTV04R8OACTIB
AVOCADO OIL6VNO72PFC1IACT
CAPRYLYL GLYCOL00YIU5438UIACT
DIMETHICONE 1000MCU2324216IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
SUNFLOWER OIL3W1JG795YIIACT
CETYL ALCOHOL936JST6JCNIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
28229d92-68bd-3781-e054-00144ff8d46c28229d92-68bc-3781-e054-00144ff8d46c2015-12-30WarningsExact identifier
spl id: 28229d92-68bd-3781-e054-00144ff8d46c
spl set id: 28229d92-68bc-3781-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.