MENOPAUSE RELIEF HOMEOPATHIC REMEDY- sepia cream

Menopause Relief Homeopathic Remedy by

Drug Labeling and Warnings

Menopause Relief Homeopathic Remedy by is a Homeopathic medication manufactured, distributed, or labeled by Homeocare Laboratories Inc., HomeoCare Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

PURPOSE

Relieves Menopausal Symptoms

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

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

INACTIVE INGREDIENT

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

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

QUESTIONS

QUESTIONS?

(877) 208-1555

DOSAGE & ADMINISTRATION

DIRECTIONS

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

DO NOT USE

DO NOT USE

In eyes, or on broken skin

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

WARNINGS

WARNINGS

For external use only

INDICATIONS & USAGE

USES

Relieves menopausal symptoms

Hot flashes, night sweats, headaches

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENOPAUSE RELIEF HOMEOPATHIC REMEDY 
sepia cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61727-054
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	4 [hp_X]  in 60 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	12 [hp_X]  in 60 mL
LACHESIS MUTA WHOLE (UNII: 6Y582I290C) (LACHESIS MUTA WHOLE - UNII:6Y582I290C)	LACHESIS MUTA WHOLE	12 [hp_X]  in 60 mL
DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA ROOT - UNII:IWY3IWX2G8)	DIOSCOREA VILLOSA ROOT	1 [hp_X]  in 60 mL
ACTAEA CIMICIFUGA ROOT (UNII: 65J267BAZT) (ACTAEA CIMICIFUGA ROOT - UNII:65J267BAZT)	ACTAEA CIMICIFUGA ROOT	4 [hp_X]  in 60 mL
CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U)	CHAMAELIRIUM LUTEUM ROOT	6 [hp_X]  in 60 mL
SEPIA ESCULENTA WHOLE (UNII: 6ET21QP634) (SEPIA ESCULENTA WHOLE - UNII:6ET21QP634)	SEPIA ESCULENTA WHOLE	12 [hp_X]  in 60 mL
SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O)	SUS SCROFA OVARY	12 [hp_X]  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
2,4-DIAMINO-5-METHYLPHENOXYETHANOL HYDROCHLORIDE (UNII: Z28JS1XMY2)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYETHYLENE OXIDE 1000000 (UNII: HZ58M6D839)
WATER (UNII: 059QF0KO0R)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
AVOCADO OIL (UNII: 6VNO72PFC1)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE 1000 (UNII: MCU2324216)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CETYL ALCOHOL (UNII: 936JST6JCN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61727-054-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/30/2015

Labeler - Homeocare Laboratories Inc. (088248828)

Establishment
Name	Address	ID/FEI	Business Operations
HomeoCare Laboratories Inc.		088248828	manufacture(61727-054)