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Colloidal oatmeal - Medication Information

Product NDC Code 79481-9965
Drug Name

Colloidal oatmeal

Type Generic
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 MEIJER
Packages
Package NDC Code Description
79481-9965-1 207 g in 1 tube (79481-9965-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient 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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, pathenol, dimethicone, Avena sativa (oat) kernel oil, steareth-20, Avena sativa (oat) kernel extract, benzalkonium chloride, ceramide NP, sodium chloride, benzyl alcohol, sodium hydroxide

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.
Colloidal oatmeal Colloidal oatmeal WATER GLYCERIN DISTEARYLDIMONIUM CHLORIDE PETROLATUM ISOPROPYL PALMITATE CETYL ALCOHOL PANTHENOL DIMETHICONE OAT KERNEL OIL STEARETH-20 OAT BENZALKONIUM CHLORIDE CERAMIDE 3 SODIUM CHLORIDE BENZYL ALCOHOL SODIUM HYDROXIDE 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.
Principal Panel Display Meijer Compare to Aveeno Eczema Therapy Moisturizing Cream* eczema soothing MOISTURIZING CREAM with Colloidal Oatmeal Skin Protectant Soothes dry, irritated, itch skin resulting from eczema Steroid free Fragrance free Dermatologist tested NET WT 7.3 OZ (207 g) image description

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.
Disclaimer *This product is not manufactured or distributed by Kenvue, Inc., distributor of Aveeno ® Eczema Therapy Moisturizing Cream. OUR QUALITY GUARANTEE The Meijer Family www.meijer.com/satisfaction Questions 1-888-593-0593 DISTRIBUTED By MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544 www.meijer.com

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.

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 withing 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

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