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| Product NDC Code | 24208-495 | ||||
|---|---|---|---|---|---|
| Drug Name | Soothe |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| RxCUI drug identifier | 832115, 1098601 |
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| Application Number | part349 | ||||
| Labeler Name | Bausch & Lomb Incorporated | ||||
| 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 Glycerin (0.6%) Propylene glycol (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 • to open, completely twist off tab • instill 1 to 2 drops in the affected eye(s) as needed • discard dispenser immediately after use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients boric acid, hydroxyalkylphosphonate, purified water, sodium alginate, sodium borate
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 • relieves dryness of the eye • prevents further irritation
Purpose
Information about the drug product’s indications for use.Purpose Lubricant Lubricant
Spl product data elements
Usually a list of ingredients in a drug product.Soothe glycerin and propylene glycol GLYCERIN GLYCERIN PROPYLENE GLYCOL PROPYLENE GLYCOL BORIC ACID WATER SODIUM ALGINATE SODIUM BORATE
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.Package/Label Principal Display Panel Bausch & Lomb Soothe® Lubricant Eye Drops PRESERVATIVE FREE Dry Eye Therapy Moisturizes Comforts Lasts Recommended for LASIK dryness* 30 Single-Use Vials Sterile 0.02 FL OZ EA (0.6 mL EA) 3839601 SootheEyeDrops.com Order No. 622219 carton-3839601
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 • store at 15 – 25 °C (59 – 77 °F)
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? [phone icon] Call: 1-800-553-5340 Marketed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Soothe is a trademark of| Bausch & Lomb Incorporated or its affiliates. © 2022 Bausch & Lomb Incorporated or its affiliates Product of France
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 • 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 • once opened, discard • do not reuse
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 solution changes color or becomes cloudy • if single-unit dispenser is not intact When using this product • do not touch tip of container to any surface to avoid contamination • once opened, discard • do not reuse Stop use and ask a doctor if • you experience eye pain, changes in vision, continued redness or irritation of the eye • condition worsens or persists for 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