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Product NDC Code | 83506-018 | ||||
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Drug Name | Hcs alcohol prep pad medium |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SWAB | ||||
RxCUI drug identifier | 797544 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Concordance Healthcare Solutions, LLC. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Isopropyl Alcohol USP, 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: Open packet, remove pad and apply topically as needed on intended area until clean. Discard prep pad after single use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: 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 the skin prior to injection; to decrease germs in minor cuts and scrapes.
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.HCS Alcohol Prep Pad Medium Isopropyl alcohol Isopropyl Alcohol Isopropyl Alcohol Water HCS Alcohol Prep Pad Large Isopropyl alcohol Isopropyl Alcohol Isopropyl 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 – Large 100 count Box Label HCS NDC 83506-009-02 Sterile, Pin Dot Texture Alcohol Prep Pads For Individual, Professional, and Hospital use Saturated with 70% v/v Isopropyl Alcohol 2-ply, sterile Use for preparation and cleansing Not made with natural rubber latex Sterility guaranteed unless package is damaged or open. Large 100/box Single Use Only Reorder Number HCS0207 Principal Display Panel – Large 100 count Box Label
Principal Display Panel – Medium 200 count Box Label HCS NDC 83506-018-02 Sterile, Pin Dot Texture Alcohol Prep Pads For Individual, Professional, and Hospital use Saturated with 70% v/v Isopropyl Alcohol 2-ply, sterile Not made with natural rubber latex Medium 200/box Single Use Only Reorder Number HCS0206 Principal Display Panel – Medium 200 count Box Label
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 apply to irritated skin. Do not use in the eyes, or on mucous membranes. In case of deep or puncture wounds, consult a doctor. Do not use with electrocautery procedures.
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 immediately.
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. Sterile in unopened, undamaged package.
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 and flame. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Do not apply to irritated skin. Do not use in the eyes, or on mucous membranes. In case of deep or puncture wounds, consult a doctor. Do not use with electrocautery procedures.
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