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Product NDC Code | 47682-194 | ||||
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Drug Name | Green guard lubricant eye drops |
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Type | Brand | ||||
Active Ingredients |
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Route | OPHTHALMIC | ||||
Dosage Form | SOLUTION | ||||
RxCUI drug identifier | 1188426 | ||||
Application Number | M018 | ||||
Labeler Name | UniFirst First Aid Corporation | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Carboxymethylcellulose sodium 0.5%
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 to open, twist and pull tab to remove instill 1 or 2 drops in the affected eye(s) as needed and discard container if used for post-operative (e.g.,LASIK) dryness and discomfort, follow your eye doctor's instructions
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients calcium chloride, **hydrochloric acid, magmesium chloride, potassium chloride, purified water, sodium chloride, **sodium hydroxide, sodium lactate ** May contain these ingredients to adjust pH
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, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun for use a protectant against further irritation
Purpose
Information about the drug product’s indications for use.Purpose Eye lubricant
Spl product data elements
Usually a list of ingredients in a drug product.Green Guard Lubricant Eye Drops carboxymethylcellulose sodium MAGNESIUM CHLORIDE WATER SODIUM HYDROXIDE SODIUM LACTATE SODIUM CHLORIDE POTASSIUM CHLORIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CARBOXYMETHYLCELLULOSE HYDROCHLORIC ACID CALCIUM CHLORIDE
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.Preservative-free Lubricant eye drops NDC 47682-194-84 *Compare to the active ingredients in Refresh Plus® Carboxymethylcellulose Sodium 0.5% Eye Lubricant Immediate, long-lasting relief for dry, irritated eyes Green Guard Sterile 30 Single-Use Containers 0.01 fl oz (0.4 mL) each Lubricant
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.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 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 od reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
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 59º-77ºF (15º-25ºC) use only if single-use container is intact use before expiration date marked on container RETAIN THIS CARTON FOR FUTURE REFERENCE
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? 1-800-869-6970
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 occur redness or irritation of the eye continues redness or irritation of the eye 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 reuse once opened, discard to avoid contamination, do not touch tip of container to any surface do not touch unit-dose tip to 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 external use 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