Label: CALM ECZEMA THERAPY WASH- sulphur 12x liquid

  • 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 January 30, 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

    Use

    • 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

    • Suitable for adults, children, and babies (except for premature babies)
      • squeeze wash onto wet hands and work into a rich foamy lather
      • wash face and body, then rinse

    Inactive Ingredients

    allantoin, ammonium laureth sulfate, Chinese rhubarb (Rheum palmatum) root extract, citric acid, common purslane (Portulaca oleracea) extract, decyl glucoside, disodium laureth sulfosuccinate, glycerin, PEG-150 distearate, pentadecalactone, polyquaternium-10, sodium benzoate, sodium cocoamphoacetate, soapberry (Sapindus mukurossi) fruit extract, water

  • 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
    Paterson, NJ 07503
    1-855-626-6606

    www.KamedisUSA.com

  • PRINCIPAL DISPLAY PANEL - 200 mL Tube Label

    Kamedis®
    Skin Restoring Solutions

    CALM
    Eczema Therapy
    Wash

    SKIN TREATMENT
    Gentle foaming cleanser for
    dry, red, itchy skin due to
    eczema.

    DERMATOLOGIST
    RECOMMENDED
    With Allantoin, Glycerin,
    Sulphur. Free from
    Parabens, Steroids, Dyes,
    Fragrance. Safe for babies.
    HOMEOPATHIC

    BOTANIPLEX
    TECHNOLOGY

    PRINCIPAL DISPLAY PANEL - 200 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    CALM ECZEMA THERAPY WASH 
    sulphur 12x liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50718-0012
    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
    ALLANTOIN (UNII: 344S277G0Z)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    PENTADECALACTONE (UNII: OK17S3S98K)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
    WATER (UNII: 059QF0KO0R)  
    RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
    SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)  
    PURSLANE (UNII: M6S840WXG5)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50718-0012-1200 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    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(50718-0012)