Label: CALM ECZEMA THERAPY CREAM- sulphur 12x 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 February 12, 2024

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

  • Drug Facts

    Active ingredient

    Sulphur 12X HPUS*
    * The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

    Purpose

    Skin Treatment

    Uses

    • temporarily protects and helps relieve minor skin irritation and itching due to:

    • rashes
    • eczema

    Warnings

    For external use only

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away

    Directions

    • adults and children 6 months of age and older
      • apply twice daily or as needed
      • massage cream into skin until fully absorbed
    • for babies under 6 months, consult a doctor

    Inactive ingredients

    acetylated lanolin alcohol, Baikal skullcap (Scutellaria baicalensis) root extract, benzyl alcohol, caprylic/capric triglyceride, carbomer, ceramide AP, ceramide EOP, ceramide NP, cetearyl alcohol, cetearyl ethylhexanoate, cetearyl glucoside, cetyl acetate, cetyl alcohol, Chinese rhubarb (Rheum palmatum) root extract, cholesterol, dehydroacetic acid, dimethicone, glycerin, glyceryl stearate, great burnet (Sanguisorba officinalis) root extract, hyaluronic acid, lactic acid, licorice (Glycyrrhiza glabra) root extract, magnesium aspartate, mineral oil, Monnier's snowparsley (Cnidium monnieri) fruit extract, oleyl acetate, PEG-100 stearate, petrolatum, phytosphingosine, potassium aspartate, potassium sorbate, propylene glycol, sarcosine, shea butter (Butyrospermum parkii), sodium cocoyl amino acids, sodium lauroyl lactylate, stearyl acetate, sucrose stearate, tree of heaven (Ailanthus altissima) bark extract, vitamin E (tocopheryl acetate), water, xanthan gum

  • SPL UNCLASSIFIED SECTION

    Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

    Made in USA
    (US and non US ingredients) Manufactured
    for Kamedis Inc. Paterson, NJ 07503

    www.kamedis.com

  • PRINCIPAL DISPLAY PANEL - 150 mL Tube Carton

    Kamedis®
    Skin Restoring Solutions

    BOTANIPLEX
    TECHNOLOGY

    CALM

    Eczema
    Therapy
    Cream

    SKIN TREATMENT
    Clinically proven to reduce
    eczema flare-ups. Relieves and
    calms dry, itchy, irritated skin
    due to eczema and rashes.

    DERMATOLOGIST
    RECOMMENDED
    Shea butter, Ceramides,
    Sulphur, free from Parabens,
    Steroids, Dyes, Fragrance,
    HOMEOPATHIC

    150mL
    5.07 fl oz

    PRINCIPAL DISPLAY PANEL - 150 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    CALM ECZEMA THERAPY CREAM 
    sulphur 12x cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50718-0011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETYL ACETATE (UNII: 4Q43814HXS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    9-OCTADECENYL ACETATE, (9Z)- (UNII: EU1ETP025C)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    POTASSIUM ASPARTATE (UNII: OC4598NZEQ)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SARCOSINE (UNII: Z711V88R5F)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    STEARYL ACETATE (UNII: A8005KSX95)  
    SUCROSE STEARATE (UNII: 274KW0O50M)  
    AILANTHUS ALTISSIMA BARK (UNII: 5YM66ALY0U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    sodium cocoyl wheat amino acids (UNII: JW3VT57I11)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50718-0011-11 in 1 CARTON01/01/2018
    1150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2018
    Labeler - Kamedis (080311300)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biogenesis Inc.069117328manufacture(50718-0011)