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| Product NDC Code | 53329-074 | ||||
|---|---|---|---|---|---|
| Drug Name | Remedy barrier cream cloths fragrance free |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CLOTH | ||||
| RxCUI drug identifier | 1534833 | ||||
| Application Number | M016 | ||||
| Labeler Name | Medline Industries, LP | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Dimethicone 3.6% w/w
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 Open package as designated Remove fresh cloths and thoroughly cleanse soiled area as needed Dispose of cloths in waste receptacle, do not flush in toilet Single Patient Use only
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients algae extract, allantoin, butylene glycol, butyrospermum parkii (shea butter) extract, C12-20 alkyl glucoside, C14-22 alcohols, camellia sinensis (green tea) extract, caprylic/capric triglyceride, cetyl alcohol, citric acid, cocoglucoside, coconut alcohol, 7- dehydrocholesterol, disodium cocoamphodiacetate, ethylene brassylate, ethylhexylglycerin, eugenia caryophyllus (clove) flower extract, glycerin, glycine soja (soybean) oil, helianthus annuus (sunflower) seed oil, hydrolyzed soy protein, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, isohexadecane, isopropyl myristate, lecithin, methyldihydrojasmonate, phenoxyethanol, phospholipids, polysorbate 60, tocopheryl acetate, urea, vanilla plantifolia fruit extract, water, 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 helps protect from minor skin irritations associated with perineal dermatitis temporarily protects and helps relieve chapped or cracked skin helps 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.Remedy Barrier Cream Cloths Dimethicone HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) WATER GLYCERIN SOYBEAN OIL CLOVE SHEA BUTTER LECITHIN, SOYBEAN ALLANTOIN C12-20 ALKYL GLUCOSIDE C14-22 ALCOHOLS CETYL ALCOHOL DISODIUM COCOAMPHODIACETATE MEDIUM-CHAIN TRIGLYCERIDES CITRIC ACID MONOHYDRATE COCO GLUCOSIDE COCONUT ALCOHOL ETHYLENE BRASSYLATE ETHYLHEXYLGLYCERIN BUTYLENE GLYCOL ISOPROPYL MYRISTATE METHYL DIHYDROJASMONATE (SYNTHETIC) YEAST PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE UREA 7-DEHYDROCHOLESTEROL SUNFLOWER OIL CORN OIL VANILLA DIMETHICONE DIMETHICONE GREEN TEA LEAF POLYSORBATE 60 ISOHEXADECANE PHYMATOLITHON CALCAREUM HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) Remedy Barrier Cream Cloths Fragrance Free Dimethicone PHYMATOLITHON CALCAREUM HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) ISOHEXADECANE POLYSORBATE 60 WATER GLYCERIN SOYBEAN OIL CLOVE SHEA BUTTER LECITHIN, SOYBEAN ALLANTOIN C12-20 ALKYL GLUCOSIDE C14-22 ALCOHOLS CETYL ALCOHOL DISODIUM COCOAMPHODIACETATE MEDIUM-CHAIN TRIGLYCERIDES CITRIC ACID MONOHYDRATE COCO GLUCOSIDE COCONUT ALCOHOL ETHYLHEXYLGLYCERIN BUTYLENE GLYCOL ISOPROPYL MYRISTATE METHYL DIHYDROJASMONATE (SYNTHETIC) YEAST PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE UREA 7-DEHYDROCHOLESTEROL SUNFLOWER OIL CORN OIL DIMETHICONE DIMETHICONE GREEN TEA LEAF HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)
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 V2 RE22MSC 074 Label V2 RF22MSC 078
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 imported materials www.medline.com 1-800-MEDLINE (633-5463) REF: MSC092508, MSC092507 V2 RE22MSC, V2 RF22MSC
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 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. 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 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
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect from freezing, avoid excessive heat Keep label tightly sealed Do Not Flush Cloth: made of Rayon/Polyester
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 animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor condition worsens symptoms last 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