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| Product NDC Code | 16864-440 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | New skin bandage |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LIQUID | ||||||||
| Application Number | part333A | ||||||||
| Labeler Name | Advantice Health, LLC | ||||||||
| 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 Benzethonium chloride 0.2%
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 clean affected area apply small amount on the area 1–3 times daily let dry a second coating may be applied for extra protection to remove, apply more New-Skin ® Liquid Bandage and quickly wipe off
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients amyl acetate, butyl acetate, camphor, ethyl acetate, nitrocellulose, SD alcohol 3-C (7.2% v/v)
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.Use first aid to help prevent bacterial contamination in minor cuts and scrapes
Purpose
Information about the drug product’s indications for use.Purpose First aid antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.New Skin Bandage Benzethonium Chloride Benzethonium Chloride Benzethonium ETHYL ACETATE ACETONE BUTYL ACETATE AMYL ACETATE ALCOHOL PYROXYLIN CAMPHOR (NATURAL)
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.PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box new- Skin ® Benzethonium Chloride 0.2%/First Aid Antiseptic LIQUID BANDAGE Brush ALL-IN-ONE PROTECTION Prevents Infection Seals Out Water, Dirt & Germs Helps Heal Cuts #1 pharmacist recommended Works Where Bandages Can't 1.0 FL OZ (30 mL) PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box
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
Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927
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 or puncture wounds deep cuts animal bites serious bleeding diabetes poor circulation 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 over large areas of the body longer than one week unless directed by a doctor on infected areas or wounds that are draining with other first aid products such as lotions and creams over sutures on mucous membranes
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 call 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? 1-800-345-0032
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 persists or gets worse infection occurs
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 store at temperatures above 120°F intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20-25°C (68-77°F), away from heat may temporarily sting upon application keep carton for full drug facts do not allow to come into contact with floors, countertops or other finished surfaces – will stain
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 Flammable keep away from fire or flame Do not use in the eyes over large areas of the body longer than one week unless directed by a doctor on infected areas or wounds that are draining with other first aid products such as lotions and creams over sutures on mucous membranes Ask a doctor before use if you have deep or puncture wounds deep cuts animal bites serious bleeding diabetes poor circulation serious burns When using this product do not store at temperatures above 120°F intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal Stop use and ask a doctor if condition persists or gets worse infection occurs Keep out of reach of children. If swallowed, get medical help or call 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