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| Product NDC Code | 53329-919 | ||||
|---|---|---|---|---|---|
| Drug Name | Medline |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 2047877 | ||||
| Application Number | part333A | ||||
| 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 Benzalkonium chloride 0.13% w/w Lidocaine HCl 4% 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 clean the affected area spray a small amount of this product on the area 1 to 3 times a day may be covered with a sterile bandage if bandaged, let dry first
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe vera gel, camphor, propylene glycol, purified water USP, sodium hydroxide
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 first aid to help prevent the risk of bacterial contamination in minor cuts, scrapes, and burns for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose First aid antiseptic Topical pain reliever
Spl product data elements
Usually a list of ingredients in a drug product.Medline benzalkonium chloride, lidocain hydrochloride LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS BENZALKONIUM CHLORIDE BENZALKONIUM SODIUM HYDROXIDE ALOE VERA LEAF WATER CAMPHOR (SYNTHETIC) PROPYLENE GLYCOL
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 Manufactured for: Medline Industries, Inc. Three Lakes Drive, Northfield, IL 60093 USA Made in USA of foreign and domestic materials www.medline.com 1-800-MEDLINE REF: MDSBURN4 V1RF21WIP
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns
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 in the eyes or apply over large areas of the body longer than 1 week, unless directed by a doctor in large quantities, particularly over raw surfaces or blistered areas
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 accidentally ingested, 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? 1-800-MEDLINE Monday-Friday 8:30 a.m.-5:00 p.m. EST
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 consult a doctor if condition persists or gets worse
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 contents under pressure do not puncture or incinerate store at temperatures between 45°-130°F (7°-54°C), 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 in the eyes or apply over large areas of the body longer than 1 week, unless directed by a doctor in large quantities, particularly over raw surfaces or blistered areas Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns When using this product contents under pressure do not puncture or incinerate store at temperatures between 45°-130°F (7°-54°C), avoid excessive heat Stop use and consult a doctor if condition persists or gets worse Keep out of reach of children. If accidentally ingested, 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