Calm Eczema Therapy Wash

Manufacturer
Kamedis | Biogenesis Inc.
Effective date
2024-01-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:26:02

Label at a glance#

ProductCalm Eczema Therapy Wash
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

Use

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

  • 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 200 mL Tube Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50718-0012-12024-02-13C16284748780-11030e365-2bb4-111a-e063-dadaa90a10e2Calm Eczema Therapy Wash
50718-0012-12024-01-30C16284748780-11030e365-2bb4-111a-e063-dadaa90a10e2Calm Eczema Therapy Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50718-0012-1Calm Eczema Therapy Wash200 mL in 1 TUBELIQUID2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50718-0012CALM ECZEMA THERAPY WASH (SULPHUR 12X) LIQUID [KAMEDIS]4Current NDC, Legacy NDC, 1 package rows20240213_38a3495e-6872-4cb8-bab7-1c93e1470e2c.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50718-001250718-0012-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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 WashSULPHUR 12XKamedis38a3495e-6872-4cb8-bab7-1c93e1470e2c2024-01-30WarningsExact identifier
ndc (package): 50718-0012-1
ndc (product): 50718-0012
ndc11 (package): 50718001201
spl id: de207320-7cf9-4c1a-9f60-c55e0a63885b
spl set id: 38a3495e-6872-4cb8-bab7-1c93e1470e2c

Reported adverse events (FAERS/openFDA)#

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