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Eczacalm - Medication Information

Product NDC Code 65112-250
Drug Name

Eczacalm

Type Brand
Pharm Class Allergens [CS],
Cell-mediated Immunity [PE],
Dietary Proteins [CS],
Grain Proteins [EXT],
Increased Histamine Release [PE],
Non-Standardized Food Allergenic Extract [EPC],
Non-Standardized Plant Allergenic Extract [EPC],
Plant Proteins [CS]
Active Ingredients
Oatmeal .008 g/g
Route TOPICAL
Dosage Form OINTMENT
Application Number M016
Labeler Name I Shay Cosmetics Inc
Packages
Package NDC Code Description
65112-250-02 1 tube in 1 box (65112-250-02) / 48.2 g in 1 tube (65112-250-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Organic Colloidal Oatmeal 0.8% ... Skin Protectant

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Apply as needed

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Organic Safflower Oil, Organic Beeswax, Organic Rosehip Seed Oil, Organic Flax Oil, Vitamin E From Sunflowers, Organic Horsetail, Organic Comfrey, Organic Horsetail, Organic Aloe, Organic Calendula, Organic Burdock, Organic Licorice Root, Organic Chamomile, Organic St. John’s Wort, Organic Plantain.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Temporarily protects and helps relieve minor skin irritation and itching due to: Eczema, rashes, insect bites, poison ivy, oak or sumac

Purpose

Information about the drug product’s indications for use.
Skin Protectant

Spl product data elements

Usually a list of ingredients in a drug product.
EczaCalm Skin Protectant SAFFLOWER OIL OATMEAL OATMEAL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
drug panel drug panel

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
WARNING: Keep out of reach of children.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
For external use only. Do not use on: deep puncture wounds serious burns animal bites 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

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API