Calm Eczema Therapy Cream
FDA Label NDC 50718-0011

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kamedis for the product Calm Eczema Therapy Cream (NDC 50718-0011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

  • Apply as needed

Inactive Ingredients

Acetylated Lanolin Alcohol, Baikal Skulcap (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, Monnier's Snowparsley (Cnidium Monnieri) Fruit Extract, Mineral Oil, 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.

Questions Or Comments?

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