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| Product NDC Code | 54799-917 | ||||
|---|---|---|---|---|---|
| Drug Name | Retaine mgd |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | EMULSION | ||||
| RxCUI drug identifier | 1236277 | ||||
| Application Number | part349 | ||||
| Labeler Name | OCuSOFT, Inc. | ||||
| 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 Ingredients Light Mineral Oil (0.5)................................Emollient Mineral Oil (0.5%).....................................Emollient
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 Shake well before using. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Cetalkonium chloride, glycerol, poloxamer 188, tris hydrochloride, tromethamine, tyloxapol, water for injection.
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 use as a protectant against further irritation or to relieve dryness of the eye.
Purpose
Information about the drug product’s indications for use.Emollient
Spl product data elements
Usually a list of ingredients in a drug product.retaine MGD Mineral Oil CETALKONIUM CHLORIDE GLYCERIN POLOXAMER 188 TROMETHAMINE HYDROCHLORIDE TROMETHAMINE TYLOXAPOL WATER LIGHT MINERAL OIL LIGHT MINERAL OIL MINERAL OIL MINERAL OIL Carton Label
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 - 30 sterile Single-Dose Containers 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 Use only if printed tamper seals on top and bottom flaps are intact. Drops appear as a milky white solution. Store between 15 o -30 o C (59 o -86 o F).
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 this product changes color.
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 THE REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call (800)233-5469 M-F 8:30AM-5:00PM CST or visit www.retainebrand.com
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 feel eye pain or changes in vision, continued redness or irritation of the eye. the 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 do not touch tip of container to any surface to avoid contamination. do not reuse once opened.
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 eyes 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