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| Product NDC Code | 78280-703 | ||||
|---|---|---|---|---|---|
| Drug Name | Advanced seal barrier plus pain relief |
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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 | 2373431 | ||||
| Application Number | part348 | ||||
| Labeler Name | Kericure Inc. | ||||
| 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 Ingredients: Lidocaine 2%
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: Adults & children age 2 & older. Shake well then apply spray. DO NOT RUB IN. Allow a clear, thin film to set. Apply up to 3x a day for 7 days. Children under 2 years of age consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Purified water, ethanol, polyacrylate polymer, cellulose
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: For the temporary relief of pain and itch in minor cuts, burns, scrapes, skin irritations, insect bites and sunburn
Purpose
Information about the drug product’s indications for use.Purpose: Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Advanced Seal Barrier plus Pain Relief Lidocaine LIDOCAINE LIDOCAINE WATER ALCOHOL BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) HYDROXYETHYL CELLULOSE (2000 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.Packaging image description
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.DRUG FACTS
Soothe, Seal & Protect TM Lidocaine + breathable, elastic barrier Seals in hydration for Advanced Healing Cuts • Burns • Rashes • Irritation & More KeriCureMedical.com KeriCure Inc. Baltimore, MD 21229
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.
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. Avoid contact with eyes. Do not ingest. Contact a doctor if pregnant, breastfeeding, or if condition worsens. Keep out of reach of children.
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