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| Product NDC Code | 79662-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Rain renewal eye drops |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| RxCUI drug identifier | 1188426 | ||||
| Application Number | M018 | ||||
| Labeler Name | Rain Eye Drops, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.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 Children under 6 years of age; ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.calcium chloride, hydrochloric acid, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide, sodium lactate.
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.for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun may be used as a protectant against further irritation
Purpose
Information about the drug product’s indications for use.Carboxymethylcellulose sodium.............Lubricant
Spl product data elements
Usually a list of ingredients in a drug product.Rain Renewal Eye Drops carboxymethylcellulose sodium CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM CARBOXYMETHYLCELLULOSE SODIUM HYDROXIDE CALCIUM CHLORIDE MAGNESIUM CHLORIDE SODIUM CHLORIDE WATER POTASSIUM CHLORIDE SODIUM LACTATE HYDROCHLORIC 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.Rain Renewal Eye Drops - 30 Ct - Updated package Rain Eye Drops
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 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 15°-30°C (59°-86°F) Protect from light RETAIN THIS CARTON FOR FUTURE REFERENCE
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 lasts conditions worsens or lasts more than 72 hours
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. to avoid contamination do not touch tip of container to any surface do not touch unit-dose tip to eye. do not reuse once opened, discard do not use if solution changes color or becomes cloudy. remove contact lenses before using Stop Use and ASK Doctor if you feel eye pain changes in vision occurs continued redness or irritations of the eye last conditions worsens or last more than 72 hours
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