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| Product NDC Code | 36800-972 | ||||
|---|---|---|---|---|---|
| Drug Name | Topcare health artificial tears |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 598050 | ||||
| Application Number | M018 | ||||
| Labeler Name | Topco Associates 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 Polyvinyl alcohol 0.5% Povidone 0.6%
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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, and sodium phosphate monobasic
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 for the temporary relief of discomfort due to minor irrittions of the eye, or to exposure to wind or sun
Purpose
Information about the drug product’s indications for use.Purpose Polyvinyl alcohol......................Eye lubricant Povidone.................................Eye lubricant
Spl product data elements
Usually a list of ingredients in a drug product.Topcare Health Artificial Tears polyvinyl alcohol, povidone POLYVINYL ALCOHOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED BENZALKONIUM CHLORIDE SODIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC POVIDONE POVIDONE POTASSIUM CHLORIDE WATER SODIUM CITRATE EDETATE DISODIUM EDETIC ACID SODIUM BICARBONATE DEXTROSE SODIUM PHOSPHATE, MONOBASIC
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 this product 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 the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Tamper Evident. Do not use this product if imprinted neckband is missing or broken. RETAIN THIS CARTON FOR FUTURE REFERENCE Store at 15º-30ºC (59º-86ºF)
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 or if the condition worsens or perists 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 to avoid contamination, do not touch tip of container to any surface replace cap after using. Keep container tightly closed remove contact lens before using
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 this product if solution changes color or becomes cloudy Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye or if the condition worsens or perists for more than 72 hours When using this product to avoid contamination, do not touch tip of container to any surface replace cap after using. Keep container tightly closed remove contact lens before using Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately
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