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Renew intensive skin therapy targeted eczema treatment - Medication Information

Product NDC Code 54473-410
Drug Name

Renew intensive skin therapy targeted eczema treatment

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 .5 g/50ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 240651
Application Number 505G(a)(3)
Labeler Name Melaleuca Inc.
Packages
Package NDC Code Description
54473-410-01 50 ml in 1 tube, with applicator (54473-410-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Colloidal oatmeal 1%

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 a doctor for children under 2 years of age: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
water, glycerin, petrolatum, distearyldimonium chloride, isopropyl palmitate, cetyl alcohol, allantoin, benzyl alcohol, citric acid

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: rashes eczema

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.
Renew Intensive Skin Therapy Targeted Eczema Treatment Colloidal Oatmeal PETROLATUM ISOPROPYL PALMITATE ALLANTOIN DISTEARYLDIMONIUM CHLORIDE OATMEAL OATMEAL GLYCERIN CETYL ALCOHOL WATER BENZYL ALCOHOL CITRIC ACID MONOHYDRATE

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.
Renew Intensive Skin Therapy Targeted Eczema Treatment label.jpg

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 for mild to moderate eczema store below 86 F (30 C)

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 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 avoid contact with 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

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