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Remedy skin repair - Medication Information

Product NDC Code 53329-140
Drug Name

Remedy skin repair

Type Brand
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 1.5 g/100ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 309917
Application Number M016
Labeler Name Medline Industries, LP
Packages
Package NDC Code Description
53329-140-04 118 ml in 1 tube (53329-140-04)
53329-140-23 946 ml in 1 bottle, pump (53329-140-23)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Dimethicone 1.5%

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 cream liberally until entire area is covered apply as needed

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients aloe barbadensis leafe juice, ascorbic acid, ascorbyl palmitate, canola oil, cetyl alcohol, cholecalciferol citric acid, diazolidinyl urea, glycerin, glyceryl stearate SE, glycine, hydroxytyrosol, L-proline, L-taurine, methylparaben, methylsulfonylmethane, A-acetyl-L-cysteine, niacinamide, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, PEG-100 stearate, PEG-8, propylene glycol, propylparaben, pyridoxine HCl, retinyl palmitate, stearic acid, stearyl alcohol, tetrasodium EDTA, tocopherol, 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 helps relieve chapped or cracked skin. Beneficial for face, hands, body and legs.

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.
Remedy Skin Repair Dimethicone ALOE VERA LEAF ASCORBIC ACID ASCORBYL PALMITATE CANOLA OIL CETYL ALCOHOL CHOLECALCIFEROL CITRIC ACID MONOHYDRATE DIAZOLIDINYL UREA GLYCERIN GLYCERYL MONOSTEARATE GLYCINE PROLINE TAURINE METHYLPARABEN DIMETHYL SULFONE ACETYLCYSTEINE NIACINAMIDE OLIVE OIL POLYETHYLENE GLYCOL 400 PEG-100 STEARATE PROPYLENE GLYCOL PROPYLPARABEN PYRIDOXINE HYDROCHLORIDE VITAMIN A PALMITATE STEARIC ACID STEARYL ALCOHOL EDETATE SODIUM .ALPHA.-TOCOPHEROL TROLAMINE WATER DIMETHICONE DIMETHICONE

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 Label Package 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.
Manufacturing Information Medline Remedy is a registered trademark of Medline Industries, Inc. Olivamine is a registered trademark of McCord Research, Inc. Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA of domestic and imported materials www.medline.com 1-800-MEDLINE REF: MSC094842UNSC RB18WAR

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on deep or puncture wounds, on animal bites, or serious burns

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 from freezing, avoid excessive heat

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 for 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. Do not use on deep or puncture wounds, on animal bites, or serious burns When using this product do not get into eyes. Stop use and ask a doctor if condition worsens, symptoms last for 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