Label: MENOPAUSE RELIEF HOMEOPATHIC REMEDY- sepia cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated December 30, 2015

If you are a consumer or patient please visit this version.

  • 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

    LABEL

  • INGREDIENTS AND APPEARANCE
    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)