{"active_ingredient":["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"],"dosage_and_administration":["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"],"effective_time":"20240212","id":"0e574a00-33bc-40d9-8ffb-21ce88215401","inactive_ingredient":["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"],"indications_and_usage":["Uses • temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema"],"keep_out_of_reach_of_children":["Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away"],"openfda":{"brand_name":["Calm Eczema Therapy Cream"],"generic_name":["SULPHUR 12X"],"is_original_packager":[true],"manufacturer_name":["Kamedis"],"package_ndc":["50718-0011-1"],"product_ndc":["50718-0011"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["0e574a00-33bc-40d9-8ffb-21ce88215401"],"spl_set_id":["304d3afc-dc81-4e8b-821c-47c5402ddf45"],"substance_name":["SULFUR"],"unii":["70FD1KFU70"]},"package_label_principal_display_panel":["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"],"purpose":["Purpose Skin Treatment"],"set_id":"304d3afc-dc81-4e8b-821c-47c5402ddf45","spl_product_data_elements":["Calm Eczema Therapy Cream Sulphur 12X SULFUR SULFUR ACETYLATED LANOLIN ALCOHOLS SCUTELLARIA BAICALENSIS ROOT BENZYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CERAMIDE AP CERAMIDE 1 CERAMIDE NP CETOSTEARYL ALCOHOL CETEARYL ETHYLHEXANOATE CETEARYL GLUCOSIDE CETYL ACETATE CETYL ALCOHOL RHEUM PALMATUM ROOT CHOLESTEROL DEHYDROACETIC ACID DIMETHICONE GLYCERIN GLYCERYL STEARATE SE SANGUISORBA OFFICINALIS ROOT HYALURONIC ACID LACTIC ACID, UNSPECIFIED FORM GLYCYRRHIZA GLABRA MAGNESIUM ASPARTATE CNIDIUM MONNIERI FRUIT MINERAL OIL 9-OCTADECENYL ACETATE, (9Z)- PEG-100 STEARATE PETROLATUM PHYTOSPHINGOSINE POTASSIUM ASPARTATE POTASSIUM SORBATE PROPYLENE GLYCOL SARCOSINE SHEA BUTTER SODIUM LAUROYL LACTYLATE STEARYL ACETATE SUCROSE STEARATE AILANTHUS ALTISSIMA BARK .ALPHA.-TOCOPHEROL ACETATE WATER XANTHAN GUM sodium cocoyl wheat amino acids"],"spl_unclassified_section":["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","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"],"stop_use":["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"],"version":"5","warnings":["Warnings For external use only"],"when_using":["When using this product do not get into eyes"]}