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| Product NDC Code | 36800-978 | ||||
|---|---|---|---|---|---|
| Drug Name | Topcare health lubricant eye drops |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 477589 | ||||
| Application Number | M018 | ||||
| Labeler Name | Topco Assoc LLC | ||||
| 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 Polyethylene glycol 400 0.4% Propylene glycol 0.3%
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 Instill 1 or 2 drops in the affected eye(s) as needed Children under 6 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc 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 the temporary relief of burning and irritation due to dryness of the eye
Purpose
Information about the drug product’s indications for use.Purpose Polyethylene glycol 400.....Lubricant Propylene glycol........Lubricant
Spl product data elements
Usually a list of ingredients in a drug product.Topcare Health Lubricant Eye Drops polyethylene glycol 400, propylene glycol SODIUM CHLORIDE ZINC CHLORIDE CALCIUM CHLORIDE HYPROMELLOSE, UNSPECIFIED PROPYLENE GLYCOL PROPYLENE GLYCOL MAGNESIUM CHLORIDE POTASSIUM CHLORIDE WATER SODIUM BORATE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 400 BENZALKONIUM CHLORIDE BORIC ACID
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.carton
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 or becomes cloudy if you are sensitive to any ingredient in this product
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information RETAIN THIS CARTON FOR FUTURE REFERENCE Store at room temperature
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 changes in vision occur redness or irritation of the eye(s) gets worse or lasts 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 the tip of container to any surface to avoid contamination replace cap after each 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 Do not use if this product changes color or becomes cloudy if you are sensitive to any ingredient in this product When using this product do not touch the tip of container to any surface to avoid contamination replace cap after each use Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eye(s) gets worse or lasts more than 72 hours 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