Systane Day And Night Value Pack
Polyethylene Glycol 400, Propylene Glycol 0.3%
Alcon Laboratories, Inc.
Human Otc Drug
NDC 0065-1502Systane Day And Night Value Pack also known as Polyethylene Glycol 400, Propylene Glycol 0.3% is a human otc drug labeled by 'Alcon Laboratories, Inc.'. National Drug Code (NDC) number for Systane Day And Night Value Pack is 0065-1502. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Systane Day And Night Value Pack drug includes . The currest status of Systane Day And Night Value Pack drug is Active.
Drug Information:
| Drug NDC: | 0065-1502 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Systane Day And Night Value Pack |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Polyethylene Glycol 400, Propylene Glycol 0.3% |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Alcon Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 24 Oct, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part349 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Alcon Laboratories, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 477589
895753
1989901
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0065-1502-10 | 1 KIT in 1 CARTON (0065-1502-10) * 10 mL in 1 BOTTLE * 10 mL in 1 BOTTLE | 24 Oct, 2017 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Active ingredients purpose polyethylene glycol 400 0.4% lubricant propylene glycol 0.3% lubricant
Active ingredients purpose polyethylene glycol 400 0.4% lubricant propylene glycol 0.3% lubricant
Product Elements:
Systane day and night value pack polyethylene glycol 400, propylene glycol 0.3% systane ultra lubricant eye drops polyethylene glycol 400, propylene glycol polyethylene glycol 400 polyethylene glycol 400 propylene glycol propylene glycol aminomethylpropanol boric acid guar gum polidronium chloride potassium chloride water sodium chloride hydrochloric acid sodium hydroxide systane drops polyethylene glycol 400, propylene glycol polyethylene glycol 400 polyethylene glycol 400 propylene glycol propylene glycol aminomethylpropanol boric acid edetate disodium guar gum polidronium chloride potassium chloride sodium chloride sorbitol water hydrochloric acid sodium hydroxide daynight ultra bottle label daynight gel drop bottle label carton carton ultra daynight bottle label bottle label
Indications and Usage:
Uses temporary relief of burning and irritation due to dryness of the eye temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun
Uses temporary relief of burning and irritation due to dryness of the eye temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun
Warnings:
Warnings for external use only
Warnings for external use only
Do Not Use:
Warnings for external use only
Warnings for external use only
When Using:
When using this product do not touch tip of container to any surface to avoid contamination replace cap after each use
When using this product do not touch tip of container to any surface to avoid contamination replace cap after each use
Dosage and Administration:
Directions shake well before using put 1 or 2 drops in the affected eye(s) as needed
Directions shake well before using put 1 or 2 drops in the affected eye(s) as needed
Stop Use:
Stop use and ask a doctor if you experience any of the following: eye pain changes in vision continued redness or irritation of the eye condition worsens or persists for more than 72 hours
Stop use and ask a doctor if you experience any of the following: eye pain changes in vision continued redness or irritation of the eye condition worsens or persists for more than 72 hours
Package Label Principal Display Panel:
Package label.principal display panel day & night value pack systane ® ultra lubricant eye drops high performing dry eye relief daytime fast-acting hydration and lasting relief moisture-rich formula #1 doctor recommended brand 1 gel drops lubricant eye gel soothing dry eye relief nighttime long-lasting formula day or night protection liquid gel sterile two 10 ml bottles (1/3 fl oz each) alcon ® this value pack gives you fast-acting hydration and long-lasting relief, for day or night protection. actual size bottles tamper evident: for your protection, each bottle has an imprinted seal around the neck. do not use if seal is damaged or missing at time of purchase. www.alconpatents.com alcon laboratories, inc. fort worth, tx 76134 usa made in usa from domestic and foreign materials 300048647-0621 lot: exp.: day & night value pack systane ® ultra lubricant eye drops high performing dry eye relief daytime fast-acting hydration and lasting relief moisture-rich formula #1 doctor recommended brand 1 gel drops lubricant eye gel soothing dry eye relief nighttime long-lasting formula day or night protection liquid gel sterile two 10 ml bottles (1/3 fl oz each) alcon ® this value pack gives you fast-acting hydration and long lasting relief, for day or night protection. actual size bottles tamper evident: for your protection, each bottle has an imprinted seal around the neck. do not use if seal is damaged or missing at time of purchase. www.alconpatents.com © 2018 novartis alcon laboratories, inc. fort worth, tx 76134 usa made in usa from domestic and foreign materials 9015877-0218 lot: exp.: systane ® ultra lubricant eye drops high performance sterile 10 ml (1/3 fl oz) for external use only. indications: for the temporary relief of burning and irritation due to dryness of the eye. directions: shake well and instill 1 or 2 drops in the affected eye(s) as needed. warnings: see carton for warnings. ingredients: actives: polyethylene glycol 400 0.4%, propylene glycol 0.3%. inactives: aminomethylpropanol, boric acid, hydroxypropyl guar, polyquad® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. may contain hydrochloric acid and/or sodium hydroxide to adjust ph. store at room temperature. alcon laboratories, inc. fort worth, tx 76134 usa alcon ® lot: exp.: 300055616-1221 systane ® ultra lubricant eye drops high performance sterile 10 ml (1/3 fl oz) for external use only. indications: for the temporary relief of burning and irritation due to dryness of the eye. directions: shake well and instill 1 or 2 drops in the affected eye(s) as needed. warnings: see carton for warnings. ingredients: actives: polyethylene glycol 400 0.4%, propylene glycol 0.3%. inactives: aminomethylpropanol, boric acid, hydroxypropyl guar, polyquad® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. may contain hydrochloric acid and/or sodium hydroxide to adjust ph. store at room temperature. alcon laboratories, inc. fort worth, tx 76134 usa alcon ® lot: exp.: h14351-0516 systane ® gel drops lubricant eye gel soothing dry eye relief sterile 10 ml (1/3 fl oz) for external use only. uses: see carton for uses. warnings: see carton for warnings. directions: shake well and put 1 or 2 drops in the affected eye(s) as needed. ingredients: actives: polyethylene glycol 0.4% and propylene glycol 0.3%. inactives: aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, polyquad® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. may contain hydrochloric acid and/or sodium hydroxide to adjust ph. store at room temperature. alcon laboratories, inc. fort worth, tx 76134 usa alcon lot: exp.: 300048641-0621 systane ® gel drops lubricant eye drops anytime protection sterile 10 ml (1/3 fl oz) for external use only. indications: for the temporary relief of burning and irritation due to dryness of the eye. directions: shake well and instill 1 or 2 drops in the affected eye(s) as needed. warnings: see carton for warnings. ingredients: actives: polyethylene glycol 0.4% and propylene glycol 0.3%.. inactives: aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, polyquad® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. may contain hydrochloric acid and/or sodium hydroxide to adjust ph.. store at room temperature. alcon laboratories, inc. 6201 south freeway, fort worth, tx 76134 usa ©2010, 2013 novartis alcon ® lot: exp.: h14343-0416
Further Questions:
Questions? in the u.s. call 1-800-757-9195 alcon.medinfo@alcon.com www.systane.com
Questions? in the u.s. call toll free 1-800-757-9195 alcon.medinfo@alcon.com www.systane.com