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Product NDC Code | 0363-7500 | ||||
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Drug Name | Walgreens sodium chloride ophthalmic 5 percent hypertonicity eye |
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Type | Brand | ||||
Active Ingredients |
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Route | OPHTHALMIC | ||||
Dosage Form | OINTMENT | ||||
RxCUI drug identifier | 1298435 | ||||
Application Number | part349 | ||||
Labeler Name | Walgreen Company | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium Chloride, 50 mg (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 • pull down lower lid of the affected eye(s) and apply a small amount (1/4 inch) to the inside of the eyelid and apply every 3-4 hours, or as directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients lanolin alcohol, mineral oil, water for injection and white petrolatum.
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 temporary relief of corneal edema.
Purpose
Information about the drug product’s indications for use.Purpose Hypertonicity Agent
Spl product data elements
Usually a list of ingredients in a drug product.Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye Sodium Chloride MINERAL OIL WATER PETROLATUM SODIUM CHLORIDE CHLORIDE ION LANOLIN ALCOHOLS
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 0363-7500-50 Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment NET WT 0.125 OZ (3.5 g) Carton 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.Walgreens Sodium Chloride Ophthalmic Ointment 5% Hypertonicity Eye Ointment 3.5g NDC 0363- 7500 -50 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 this product except under the advice and supervision of 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 THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN . If swallowed, 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 • Store at room temperature 15°- 30°C (59°- 86°F). • Do not freeze. • Keep tightly closed. • See crimp of tube or box for lot number and expiration date.
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 ? •1- 800-925-4733
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 • you experience eye pain, changes in vision, continued redness or irritation of the eye. • condition worsens or persists for more than 72 hours.
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 touch tip of container to any surface. • replace cap after use. • this product may cause temporary burning and irritation on being instilled into the eye.
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 use in the eye s only. • Retain outer carton for full product drug facts. Do not use this product except under the advice and supervision of a doctor. When using this product • avoid contamination, do not touch tip of container to any surface. • replace cap after use. • this product may cause temporary burning and irritation on being instilled into the eye. Stop use and ask a doctor if • you experience eye pain, changes in vision, continued redness or irritation of the eye. • condition worsens or persists for more than 72 hours. KEEP THIS AND ALL DRUGS OUT OF THE 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