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| Product NDC Code | 17271-503 | ||||
|---|---|---|---|---|---|
| Drug Name | Bd e-z scrub |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Becton Dickinson and Company | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Povidone-Iodine 6.5% w/w (minimum available Iodine 0.5%)
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 Surgical Hand Scrub Wet hands and forearms with warm water Use nail cleaner and then apply solution from the sponge side to work up a lather Scrub thoroughly for 3 minutes: difficult areas (interdigital space and fingers) with brush side, hands and forarms with sponge side Rinse thoroughly with warm water Repeat scrub for 3 minutes, sponge side only Rinse hands and arms thoroughly Dry thoroughly Health Care Personnel Handwash Dispense about 5 ml of foam solution into cupped hands Wash in a vigorous manner covering all surfaces for 30 seconds Rinse thoroughly with running water (30 seconds)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients ammonium nonoxynol sulfate, disodium phosphate, hydrogen peroxide, octoxynol, phosphoric acid, sodium hydroxide, 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 surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
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.BD E-Z Scrub Povidone-Iodine AMMONIUM NONOXYNOL-4 SULFATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE HYDROGEN PEROXIDE OCTOXYNOL 9 PHOSPHORIC ACID SODIUM HYDROXIDE WATER POVIDONE-IODINE IODINE
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 – Bottle Label BD E-Z Scrub™ 0.5% Povidone Iodine Antiseptic Solution REF 372405 • NDC 17271-503-01 Foreign Patents and Patents Pending. U.S. Patents 6,053,369 - 6,308,866 32 FL. OZ (946 ml) Povidone-Iodine Principal Display Panel – Bottle Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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 if redness or irritation occurs
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 or gets in eyes, 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 avoid excessive heat above 104°F (40°C)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-453-4538 Monday to Friday, 8 a.m. to 5 p.m. MST
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 severe adverse reactions occur
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes
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 Do not use if redness or irritation occurs When using this product avoid contact with eyes Stop use and ask a doctor if severe adverse reactions occur Keep out of reach of children . If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.
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