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Flexitol eczema and dermatitis - Medication Information

Product NDC Code 43251-9020
Drug Name

Flexitol eczema and dermatitis

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 50 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 1595494
Application Number M016
Labeler Name LaCorium Health USA Inc
Packages
Package NDC Code Description
43251-9020-1 1 tube in 1 carton (43251-9020-1) / 56 g in 1 tube
43251-9020-2 1 g in 1 packet (43251-9020-2)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Colloidal Oatmeal 5%

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 to affected skin 2-3 times a day Smooth in gently The smallest effective dose should be used Patch test recommended on sensitive skin Suitable for use on children 2 years of age and older

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice powder, calendula officinalis flower extract, cetearyl alcohol, ceteth-20, dimethicone 100, edetate disodium, glycerin, glyceryl caprylate, glyceryl stearate, hydroxyacetophenone, isopropyl myristate, mineral oil light, phenoxyethanol, sodium benzoate, sodium stearoyl glutamate, triethanolamine, water

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 relieves minor skin irritation and itching due to: eczema dermatitis 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.
Flexitol Eczema and Dermatitis oatmeal oatmeal oatmeal Aloe Vera Leaf Water Carbomer Interpolymer type A (Allyl Sucrose Crosslinked) Calendula Officinalis Flower Cetostearyl Alcohol Ceteth-20 Dimethicone Edetate Disodium Glyceryl Monocaprylate Glyceryl Monostearate Glycerin Hydroxyacetophenone Isopropyl Myristate Mineral Oil Phenoxyethanol Trolamine SODIUM STEAROYL GLUTAMATE

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 DISPLAY PANEL - 60 g Tube Carton NDC: 43251-9020-1 Flexitol ® ECZEMA & DERMATITIS CREAM RASH RELIEF RELIEVES RASH, IRRITATION, ITCHING AND REDNESS FREE FROM CORTISONE, COAL AND PINE TAR COLLOIDAL OATMEAL 5% SKIN PROTECTANT CREAM SUITABLE FOR CHILDREN Proud Supporter eczema association australasia eaa Net Wt. 2.11 oz (60 g) PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

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

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 or Comments? Call Toll Free 1-877-687-2542 [email protected] www.flexitol.com

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 do not get into eyes If contact occurs, rinse eyes thoroughly with water. Do not use on broken skin.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information Store between 50-86°F in a dry place

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 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 this product do not get into eyes If contact occurs, rinse eyes thoroughly with water. Do not use on broken skin. 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

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