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| Product NDC Code | 53329-152 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Medline remedy phytoplex skin repair |
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| Type | Brand | ||||||||||||||
| Pharm Class | Skin Barrier Activity [PE] | ||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||
| Dosage Form | CREAM | ||||||||||||||
| RxCUI drug identifier | 259090 | ||||||||||||||
| Application Number | M016 | ||||||||||||||
| Labeler Name | Medline Industries, LP | ||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Dimethicone 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients algae extract, bisabolol, brassica campestris (rapeseed) sterols, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, caprylyl glycol, carthamus tinctorius (safflower) oleosomes, cetylhydroxyproline palmitamide, cholecalciferol, citrus paradisi (grapefruit) peel oil, citrus reticulata (tangerine) peel oil, citrus sinensis (orange) peel oil, cetyl alcohol, cocos nucifera (coconut oil), 7-dehydrocholesterol, ethylene brassylate, eugenia caryophyllus (clove) flower extract, glycerin, glyceryl stearate, glycol distearate, 1,2-hexanediol, hexyldecanol, hydrolyzed soy protein, hydroyacetophenone, isopropyl myristate, jojoba esters, manuka honey, methyldihydrojasmonate, olea europaea (olive oil), peg 100 stearate, phospholipids, phytonadione, purified water, propanediol, stearic acid, tocopherol acetate, vanilla planifolia extract, yeast ferment extract, 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 Temporarily protects and helps relieve chapped or cracked skin. Protects 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 Remedy Phytoplex Skin Repair Dimethicone GELIDIELLA ACEROSA ISOPROPYL MYRISTATE ETHYLENE BRASSYLATE CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES HYDROLYZED JOJOBA ESTERS (ACID FORM) HYDROXYACETOPHENONE METHYL DIHYDROJASMONATE (SYNTHETIC) SACCHAROMYCES CEREVISIAE OMEGA-3 FATTY ACIDS HONEY PHYTONADIONE ORANGE OIL CLOVE GREEN TEA LEAF CHOLECALCIFEROL MANDARIN OIL COCONUT OIL GRAPEFRUIT OIL 1,2-HEXANEDIOL GLYCERYL MONOSTEARATE PROPANEDIOL GLYCOL DISTEARATE CAPRYLYL GLYCOL HEXYLDECANOL .BETA.-BISABOLOL OLIVE OIL CETYLHYDROXYPROLINE PALMITAMIDE PEG-100 STEARATE GLYCERIN RAPESEED STEROL STEARIC ACID HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) 7-DEHYDROCHOLESTEROL .ALPHA.-TOCOPHEROL MEDIUM-CHAIN TRIGLYCERIDES VANILLIN WATER CORN OIL 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 Phytoplex, Medline Remedy, and Medline are registered trademarks of Medline Industries Inc. Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA. Made in USA of domestic and imported materials. www.medline.com 1-800-MEDLINE RK20BLB
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 on 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.
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 avoid contact with eyes.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect from freezing. Avoid excessive heat.
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 on serious burns When using this product avoid contact with 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