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| Product NDC Code | 65517-0002 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Dukal sterile alcohol prep pad |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SWAB | ||||||
| RxCUI drug identifier | 797544 | ||||||
| Application Number | M003 | ||||||
| Labeler Name | Dukal 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 Ingredients Isopropyl Alcohol 70% Purpose Antiseptic Cleanser
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.Other Information Store at Room Temperature 15 - 30 C (59 - 86 F)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient purified water
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.For preparation of the skin prior to injection Indications & Usage Section Updated to match label claim
Purpose
Information about the drug product’s indications for use.Use For Preparation of Skin prior to an injection
Spl product data elements
Usually a list of ingredients in a drug product.Dukal Sterile Alcohol Prep Pad ISOPROPYL ALCOHOL WATER ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL
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.Dukal Alcohol Pad Sterile Saturated with 70% Isopropyl Alcohol For External Use Only Not made with natural rubber latex / Single Use Sterility guaranteed unless package is damaged or opened Manufactured For: Dukal, LLC 1(800)243-0741 /Ronkonkoma, NY 11779 / dukal.com Made in China Dukal is a trademark registered in the US Patent & Trademark Office by Dukal, LLC 1 Per Pouch / NDC 65517-0002-1 / REF 853 853
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Indications & Usage Section Updated to match label claim
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
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 with electrocautery procedures In the Eyes. If contact occurs, flush eyes with water
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 If irritation and redness develop. If condition persists, consult your health care practitioner.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at Room Temperature 15 - 30 C (59 - 86 F)
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
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