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Product NDC Code | 83017-6895 | ||||
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Drug Name | Isopropyl alcohol |
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Type | Generic | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SWAB | ||||
RxCUI drug identifier | 797544 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | embecta Medical II, LLC | ||||
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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient 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 the preparation of skin prior to an 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.Isopropyl Alcohol 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 – 100 Swabs Carton Label embecta™ NDC 83017-6895-3 REF 326895 Alcohol Swabs Antiseptic for preparation of the skin prior to injection 100 Swabs Principal Display Panel – 100 Swabs Carton 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 in the eyes on mucous membranes. In case of deep or puncture wounds, consult a doctor. Discontinue use if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.
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 the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Caution do not apply to irritated skin.
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.
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.Warning For External use only. FLAMMABLE , keep away from fire or flame. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Caution do not apply to irritated skin. Do not use in the eyes on mucous membranes. In case of deep or puncture wounds, consult a doctor. Discontinue use if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.
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