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Soothe - Medication Information

Product NDC Code 24208-495
Drug Name

Soothe

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]
Active Ingredients
Glycerin 6 mg/ml
Propylene glycol 6 mg/ml
Route OPHTHALMIC
Dosage Form SOLUTION/ DROPS
RxCUI drug identifier 832115,
1098601
Application Number M018
Labeler Name Bausch & Lomb Incorporated
Packages
Package NDC Code Description
24208-495-30 30 vial, single-use in 1 carton (24208-495-30) / .6 ml in 1 vial, single-use
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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 BORIC ACID WATER SODIUM ALGINATE SODIUM BORATE GLYCERIN GLYCERIN PROPYLENE GLYCOL PROPYLENE GLYCOL

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