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Product NDC Code | 68786-120 | ||||||||
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Drug Name | Alcohol |
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Type | Generic | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | SWAB | ||||||||
RxCUI drug identifier | 797544 | ||||||||
Application Number | M003 | ||||||||
Labeler Name | Sion Biotext Medical Ltd | ||||||||
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: Wipe injection site vigorously and discard.
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.Uses 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.alcohol 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.Principal display panel NDC 68786-120-13 Sion Biotext Medical Ltd. Alcohol Prep Pad Sterile- Medium 2 Ply One pad saturated with 70% Isopropyl Alcohol 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 use: With electrocautery procedures In the eyes.
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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.
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 irritation and redness develop If condition persists for more than 72 hours, consult a physician.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Avoid excessive heat Store at room temperature 15 o -30 o C (59 o -86 o 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 Sterile unless pouch is opened or damaged
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