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Theraplex eczema therapy - Medication Information

Product NDC Code 82280-816
Drug Name

Theraplex eczema therapy

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 10 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 240651
Application Number M016
Labeler Name THERAPLEX, LLC
Packages
Package NDC Code Description
82280-816-00 170.1 g in 1 jar (82280-816-00)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient 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, or as directed by your doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients cyclomethicone, microcrystalline wax, petrolatum (special fraction)

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.
THERAPLEX Eczema Therapy OATMEAL CYCLOMETHICONE MICROCRYSTALLINE WAX PETROLATUM 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.
Package Labeling: Label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Other information store at room temperature keep from freezing

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? call 1-888-437-2753

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

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.

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 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.

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