MENOPAUSE RELIEF HOMEOPATHIC REMEDY- sepia cream 
Homeocare Laboratories Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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PURPOSE

Relieves Menopausal Symptoms

ACTIVE INGREDIENTS

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

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

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

QUESTIONS?

(877) 208-1555

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

In eyes, or on broken skin

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

WARNINGS

For external use only

USES

Relieves menopausal symptoms

Hot flashes, night sweats, headaches

LABEL

MENOPAUSE RELIEF HOMEOPATHIC REMEDY 
sepia cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61727-054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT4 [hp_X]  in 60 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED12 [hp_X]  in 60 mL
LACHESIS MUTA WHOLE (UNII: 6Y582I290C) (LACHESIS MUTA WHOLE - UNII:6Y582I290C) LACHESIS MUTA WHOLE12 [hp_X]  in 60 mL
DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA ROOT - UNII:IWY3IWX2G8) DIOSCOREA VILLOSA ROOT1 [hp_X]  in 60 mL
ACTAEA CIMICIFUGA ROOT (UNII: 65J267BAZT) (ACTAEA CIMICIFUGA ROOT - UNII:65J267BAZT) ACTAEA CIMICIFUGA ROOT4 [hp_X]  in 60 mL
CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT6 [hp_X]  in 60 mL
SEPIA ESCULENTA WHOLE (UNII: 6ET21QP634) (SEPIA ESCULENTA WHOLE - UNII:6ET21QP634) SEPIA ESCULENTA WHOLE12 [hp_X]  in 60 mL
SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY12 [hp_X]  in 60 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61727-054-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/30/2015
Labeler - Homeocare Laboratories Inc. (088248828)
Establishment
NameAddressID/FEIBusiness Operations
HomeoCare Laboratories Inc.088248828manufacture(61727-054)

Revised: 12/2015
Document Id: 28229d92-68bd-3781-e054-00144ff8d46c
Set id: 28229d92-68bc-3781-e054-00144ff8d46c
Version: 1
Effective Time: 20151230
 
Homeocare Laboratories Inc.