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| Product NDC Code | 0536-1253 | ||||
|---|---|---|---|---|---|
| Drug Name | Sodium chloride hypertonicity ophthalmic |
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| Type | Brand | ||||
| Pharm Class | Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC] |
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| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 1298435 | ||||
| Application Number | part349 | ||||
| Labeler Name | Rugby Laboratories | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 the lower lid of the affected eye • apply a small amount (1/4 inch) of ointment to the inside of eyelid • apply every 3 or 4 hours or as directed by a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients lanolin, mineral oil, purified water, 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.Uses 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.Sodium Chloride Hypertonicity Ophthalmic sodium chloride SODIUM CHLORIDE SODIUM CATION LANOLIN MINERAL OIL WATER PETROLATUM
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.Package/Label Principal Display Panel Carton Rugby ® NDC 0536-1253-91 Sodium Chloride Hypertonicity Ophthalmic Ointment, 5% STERILE NET WT. 1/8 OZ. (3.5 G) carton
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.Other information • store at 15° - 25°C (59° - 77°F) • keep tightly closed • DO NOT FREEZE • see crimp of tube or carton for Lot Number and Expiration Date • do not use if difficult to dispense or visible particles are seen in the product • serious side effects associated with use of the product may be reported to the phone number below
Questions [phone icon] Call 1-800-645-2158
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.
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 except under the advice and supervision of a doctor When using this product • it may cause temporary burning and irritation • replace cap after use • to avoid contamination do not touch tip of container to any surface Stop use and ask a doctor if • condition worsens or persists for more than 72 hours • you experience eye pain, changes in vision, continued redness or irritation of the eye
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