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Product NDC Code | 50685-005 | ||||
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Drug Name | Good care surgical brush with nail cleaner |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPONGE | ||||
RxCUI drug identifier | 1037204 | ||||
Application Number | part333A | ||||
Labeler Name | Dalian Goodwood Medical Care Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Povidone Iodine USP, 7.5% w/v (minimum available Iodine 0.75%) w/w
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 Clean under nails with nail pick Wet hands and forearms Scrub thoroughly for 3 minutes paying particular attention to the nail, cuticle and interdigital spaces Repeat scrub for 3 more minutes Rinse thoroughly
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, USP 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 Preoperative cleaning of healthcare personnel arms and hands. Significantly reduces the number of micro-organisms on the hands forearms prior to the surgery.
Purpose
Information about the drug product’s indications for use.Purpose Surgical Hand Scrub
Spl product data elements
Usually a list of ingredients in a drug product.Good Care Surgical Brush With Nail Cleaner POVIDONE-IODINE AMMONIUM NONOXYNOL-4 SULFATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE HYDROGEN PEROXIDE 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.Good Care Surgical Scrub Brush/ Sponge With Nail Cleaner GW1503 Povidone-Iodine
PIS1
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.Manufactured by DALIAN GOODWOOD MEDICAL CARE LTD. Made in China www.dl-goodwood.com
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 occur
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.
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Avoid excessive heat 40 degrees C (104 degrees F) Discard after single use
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.
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