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Medline - Medication Information

Product NDC Code 53329-154
Drug Name

Medline

Type Brand
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 15 mg/ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 309917
Application Number M016
Labeler Name Medline Industries, LP
Packages
Package NDC Code Description
53329-154-04 118 ml in 1 tube (53329-154-04)
53329-154-13 59 ml in 1 tube (53329-154-13)
53329-154-23 946 ml in 1 bottle, pump (53329-154-23)
53329-154-84 1000 ml in 1 bag (53329-154-84)
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Active ingredient

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

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 one ounce to full body per application, twice daily apply especially right after bath or shower for best effect

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients acetyl cysteine, aloe barbadensis leaf juice, arginine, ascorbic acid, ascorbyl palmitate, canola oil, cetyl alcohol, cholecalciferol, citric acid, dimethyl sulfone, ethylhexylglycerin, fragrance, glycerin, glyceryl stearate SE, glycine, hydrated silica, niacinamide, olea europaea (olive) fruit oil, olea europaea leaf extract, olea europaea leaf powder, oleuropein, PEG-8, PEG-100 stearate, phenoxyethanol, proline, propanediol, pyridoxine HCL, retinyl palmitate, stearic acid, stearyl alcohol, taurine, tetrasodium glutamate diacetate, tocopherol, water, zea mays (corn) oil

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 helps prevent and temporarily protects and helps relieve chapped or cracked skin helps prevent and protect from the drying effects of wind and cold weather

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.
Medline dimethicone OLIVE OIL NIACINAMIDE TETRASODIUM GLUTAMATE DIACETATE ASCORBIC ACID PYRIDOXINE HYDROCHLORIDE WATER STEARYL ALCOHOL CORN OIL .ALPHA.-TOCOPHEROL, DL- GLYCERIN STEARIC ACID VITAMIN A PALMITATE OLEUROPEIN HYDRATED SILICA CANOLA OIL CETYL ALCOHOL CHOLECALCIFEROL PHENOXYETHANOL PEG-100 STEARATE POLYETHYLENE GLYCOL 400 ASCORBYL PALMITATE DIMETHYL SULFONE PROPANEDIOL DIMETHICONE DIMETHICONE ALOE VERA LEAF ACETYLCYSTEINE TAURINE PROLINE ARGININE GLYCERYL STEARATE SE ANHYDROUS CITRIC ACID ETHYLHEXYLGLYCERIN GLYCINE

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 Label V1 RL22WAR

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 Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA with domestic and foreign materials www.medline.com 1-800-MEDLINE (633-5463) REF: MSC0924402 V1 RL22WAR

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 deep or puncture wounds animal bites 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. In case of accidental ingestion, 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 not made with Natural Rubber Latex

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.
Stope 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

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 deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stope use 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. In case of accidental ingestion, 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