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| Product NDC Code | 83584-200 | ||||
|---|---|---|---|---|---|
| Drug Name | Sterile alcohol prep pads |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CLOTH | ||||
| RxCUI drug identifier | 797544 | ||||
| Application Number | part333A | ||||
| Labeler Name | PurCel Labs 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 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 Open packet Apply topically as needed to cleanse Remove pad intended area Discard after single use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient Purifified 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 the skin prior to an injection
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.STERILE ALCOHOL PREP PADS 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.Package label.principal display panel NDC 83584-200-01 NDC 83584-200-02 NDC 83584-200-03 NDC 83584-200-04
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 electrocutery procedures Do not use in the eyes Do not apply to 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.
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
Storage and handling
Information about safe storage and handling of the drug product.Other informations Store at room temperature 59-86°F(15-30°C). Contents STERILE in unopened,undamaged inner package.
User safety warnings
When a drug can pose a hazard to human health by contact, inhalation, ingestion, injection, or by any exposure, this field contains information which can prevent or decrease the possibility of harm.If swallowed, get medical help or contact a Poison Control Center right away
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 fifire or flflame
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