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| Product NDC Code | 72598-022 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Plus rinse emergency eyewash |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||||||
| Dosage Form | LIQUID | ||||||||
| RxCUI drug identifier | 1053429 | ||||||||
| Application Number | M018 | ||||||||
| Labeler Name | INNOVATIVE SAFETY SUPPLY INC. | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Purified water 99.1%
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 do not dilute solution or reuse bottle use only unopened bottle to open, twist cap in the direction of the arrow avoid contamination of the integrated eyecup place integrated eyecup over affected eye(s) tilt head backward open eyelid(s) wide control rate of flow by pressure on bottle thoroughly bathe eye(s) with solution allow solution to flow away from eye(s) rinse until the bottle is empty and continue rinsing with Plum Emergency Eyewash until you reach a doctor continue rinsing with water if necessary obtain medical treatment.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Sterile Sodium Chloride
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 rinsing the eyes to reduce risk of severe injury caused by chemicals or particulate contamination
Purpose
Information about the drug product’s indications for use.Purpose Emergency eyewash
Spl product data elements
Usually a list of ingredients in a drug product.Plus Rinse Emergency Eyewash Purified Water SODIUM CHLORIDE WATER 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 NDC : 72598-022-20 Plus Rinse Emergency Eyewash Compliance: ANSI/ISEA Z358.1-2014 (As Personal Eyewash Only) Innovative SAFETY SUPPLY Labeler: Innovative Safety Supply Inc, 368 Edson St, Saskatoon, SK/S7J 0P9/Canada. www.plusrinse.com Sterile - 500 ml (16.9 fl oz) NDC: 72598-022-01 Plus Rinse Emergency Eyewash Compliance: ANSI/ISEA Z358.1-2014 (As Personal Eyewash Only) Innovative SAFETY SUPPLY Labeler: Innovative Safety Supply Inc, 368 Edson St, Saskatoon, SK/S7J 0P9/Canada. www.plusrinse.com Sterile - 1000 ml (33.8 fl oz) NDC: 72598-022-02 Plus Rinse Emergency Eyewash Compliance: ANSI/ISEA Z358.1-2014 (As Personal Eyewash Only) Innovative SAFETY SUPPLY Labeler: Innovative Safety Supply Inc, 368 Edson St, Saskatoon, SK/S7J 0P9/Canada. www.plusrinse.com Sterile - 200 ml (6.8 fl oz) pic1 pic2 pic3
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.Imported and distributed by Innovative Safety Supply USA Inc., 5150 West 76th St, Indianapolis, IN, 46268
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor if you have eye pain changes in vision redness or irritation of the eye after use an injury caused by alkali
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 for injection for intraocular surgery internally If solution changes color or becomes cloudy.
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, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Call toll-free number 1-844-405-7233
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 contamination do not reuse. Once opened, discard.
General precautions
Information about any special care to be exercised for safe and effective use of the drug.Other information not for use as a contact lens solution do not use after bottle expiration store at room temperature, 5° to 35° C (41° to 95°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 Do not use for injection for intraocular surgery internally If solution changes color or becomes cloudy. When using this product avoid contamination do not reuse. Once opened, discard. Ask a doctor if you have eye pain changes in vision redness or irritation of the eye after use an injury caused by alkali Keep out of reach of children If swallowed, 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