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Eczema - Medication Information

Product NDC Code 73517-425
Drug Name

Eczema

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 1 g/100ml
Route TOPICAL
Dosage Form LOTION
RxCUI drug identifier 240464
Application Number M016
Labeler Name Amyris, Inc
Packages
Package NDC Code Description
73517-425-01 1 tube in 1 carton (73517-425-01) / 177 ml in 1 tube
73517-425-02 30 ml in 1 tube (73517-425-02)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Colloidal Oatmeal 1% Purpose 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.
Directions Apply as needed

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Water, Squalane, Caprylic/Capric Triglyceride, Glycerin, Hydrogenated Sunflower Seed Oil Polyglyceryl-3 Esters, Hydroxystearic/Linolenic/Oleic Polyglycerides, Butyrospermum Parkii (Shea ) Butter, Jojoba Esters. Cetearyl Alcohol, Hydrogenated Sunflower Seed Oil Glyceryl Esters, Propanediol, Hydroxyacetophenone, Sodium Stearoyl Lactylate, Xanthan Gum, Citric Acid, Ethylhexylglycerin, Potassium Sorbate, Ceramide NP, Sodium Phytate, Tocopherol.

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.
Uses Temporarily protects and helps relieve minor skin irritation and itching due to eczema rashes

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Eczema Colloidal Oatmeal WATER SQUALANE MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN SUNFLOWER SEED OIL GLYCERETH-8 ESTERS 12-HYDROXYSTEARIC ACID SHEA BUTTER HYDROGENATED JOJOBA OIL, RANDOMIZED CETOSTEARYL ALCOHOL PROPANEDIOL HYDROXYACETOPHENONE SODIUM STEAROYL LACTYLATE XANTHAN GUM CITRIC ACID MONOHYDRATE ETHYLHEXYLGLYCERIN POTASSIUM SORBATE CERAMIDE NP HEXASODIUM PHYTATE TOCOPHEROL 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.
eczemaUC

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.
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information Protect this product from excessive heat and direct sunlight

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and aks 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.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product do not get into eyes Stop use and aks 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.

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.
Warnings For external use only When using this product do not get into eyes Stop use and aks 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.

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