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Product NDC Code | 10819-3914 | ||||||
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Drug Name | Pdi alcohol prep pad sterile large and medium |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CLOTH | ||||||
RxCUI drug identifier | 797544 | ||||||
Application Number | 505G(a)(3) | ||||||
Labeler Name | Professional Disposables International Inc | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Isopropyl Alcohol 70% v/v
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 Wet topically and discard after single use
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.Use For preparation of skin prior to an injection
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.PDI Alcohol Prep Pad Sterile Large and Medium Alcohol ALCOHOL ALCOHOL WATER
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 Alcohol Prep Pad Sterile Medium or Large Antiseptic Sterile solution Applicator is sterile if package is intact For Hospital and Home Use Settings Dispose of used wipes in trash receptacle. Do not flush. Professional Disposables International, Inc. Orangeburg, NY 10962-1376 USA - 1800-999-6423 www.pdipdi.com Packet Medium: Box Medium: Packet Large: Box Large: Packet Medium Box Medium Packet large box large
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 preocedures use in the eyes apply on irritated skin
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at room temperature (15-30ºC) (59-86ºF)
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 pain, irritation, redness or swelling occurs. discontinue use and consult a physician.
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