FDA.reportPublic FDA data

Calm Eczema Therapy Cream

Manufacturer
Kamedis | Biogenesis Inc.
Effective date
2024-02-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:26:03

Label at a glance#

ProductCalm Eczema Therapy Cream
Active ingredientSULFUR
Label structure3 sections

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Skin Treatment

Uses

INDICATIONS & USAGE SECTION

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

  • rashes
  • eczema

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 150 mL Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50718-0011-12024-02-13C16284748780-11030e365-6c31-111a-e063-dadaa90a10e2Calm Eczema Therapy Cream
50718-0011-12024-01-30C16284748780-11030e365-6c31-111a-e063-dadaa90a10e2Calm Eczema Therapy Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50718-0011-1Calm Eczema Therapy Cream150 mL in 1 TUBECREAM1505
50718-0011-1Calm Eczema Therapy Cream1 in 1 CARTONCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50718-0011CALM ECZEMA THERAPY CREAM (SULPHUR 12X) CREAM [KAMEDIS]5Current NDC, Legacy NDC, 2 package rows20240214_304d3afc-dc81-4e8b-821c-47c5402ddf45.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50718-001150718-0011-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULFUR70FD1KFU70ACTIB
ACETYLATED LANOLIN ALCOHOLSSNN716810PIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
BENZYL ALCOHOLLKG8494WBHIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CERAMIDE APF1X8L2B00JIACT
CERAMIDE 15THT33P7X7IACT
CERAMIDE NP4370DF050BIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL ETHYLHEXANOATE9M64UO4C25IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CETYL ACETATE4Q43814HXSIACT
CETYL ALCOHOL936JST6JCNIACT
RHEUM PALMATUM ROOTG025DAL7CEIACT
CHOLESTEROL97C5T2UQ7JIACT
DEHYDROACETIC ACID2KAG279R6RIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
SANGUISORBA OFFICINALIS ROOT4NYV2HT01XIACT
HYALURONIC ACIDS270N0TRQYIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
MAGNESIUM ASPARTATER17X820ROLIACT
CNIDIUM MONNIERI FRUITV1IA3S3CUSIACT
MINERAL OILT5L8T28FGPIACT
9-OCTADECENYL ACETATE, (9Z)-EU1ETP025CIACT
PEG-100 STEARATEYD01N1999RIACT
PETROLATUM4T6H12BN9UIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
POTASSIUM ASPARTATEOC4598NZEQIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SARCOSINEZ711V88R5FIACT
SHEA BUTTERK49155WL9YIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
STEARYL ACETATEA8005KSX95IACT
SUCROSE STEARATE274KW0O50MIACT
AILANTHUS ALTISSIMA BARK5YM66ALY0UIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calm Eczema Therapy CreamSULPHUR 12XKamedis304d3afc-dc81-4e8b-821c-47c5402ddf452024-02-12WarningsExact identifier
ndc (package): 50718-0011-1
ndc (product): 50718-0011
ndc11 (package): 50718001101
spl id: 0e574a00-33bc-40d9-8ffb-21ce88215401
spl set id: 304d3afc-dc81-4e8b-821c-47c5402ddf45

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.