Eyes Alive Lubricating
Carboxymethylcellulose Sodium
Division 5 Labs, Inc.
Human Otc Drug
NDC 69183-200Eyes Alive Lubricating also known as Carboxymethylcellulose Sodium is a human otc drug labeled by 'Division 5 Labs, Inc.'. National Drug Code (NDC) number for Eyes Alive Lubricating is 69183-200. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Eyes Alive Lubricating drug includes Carboxymethylcellulose Sodium, Unspecified Form - 5 mg/mL . The currest status of Eyes Alive Lubricating drug is Active.
Drug Information:
| Drug NDC: | 69183-200 |
| 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: | Eyes Alive Lubricating |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Eyes Alive |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Lubricating |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Carboxymethylcellulose Sodium |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Division 5 Labs, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM - 5 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAOCULAR
|
| 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: | 01 Feb, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 May, 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: | DIVISION 5 LABS, INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1188426
1603466
|
| 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. |
| UPC: | 0369183000024
|
| UPC stands for Universal Product Code. |
| UNII: | K679OBS311
|
| 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 |
|---|
| 69183-200-00 | 100 AMPULE in 1 CARTON (69183-200-00) / .6 mL in 1 AMPULE | 01 Feb, 2015 | N/A | No |
| 69183-200-02 | 2 AMPULE in 1 POUCH (69183-200-02) / .6 mL in 1 AMPULE | 01 Feb, 2015 | N/A | No |
| 69183-200-04 | 4 AMPULE in 1 POUCH (69183-200-04) / .6 mL in 1 AMPULE | 01 Feb, 2015 | N/A | No |
| 69183-200-08 | 8 AMPULE in 1 CARTON (69183-200-08) / .6 mL in 1 AMPULE | 01 Feb, 2015 | N/A | No |
| 69183-200-32 | 32 AMPULE in 1 CARTON (69183-200-32) / .6 mL in 1 AMPULE | 01 Feb, 2015 | N/A | No |
| 69183-200-52 | 52 AMPULE in 1 CARTON (69183-200-52) / .6 mL in 1 AMPULE | 01 Feb, 2015 | N/A | No |
| 69183-200-72 | 72 AMPULE in 1 CARTON (69183-200-72) / .6 mL in 1 AMPULE | 01 Feb, 2015 | 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:
Purpose eye lubricant
Product Elements:
Eyes alive lubricating carboxymethylcellulose sodium carboxymethylcellulose sodium, unspecified form carboxymethylcellulose calcium chloride hydrochloric acid magnesium chloride potassium chloride water sodium chloride sodium hydroxide sodium lactate
Indications and Usage:
Uses 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 of the eye.
Warnings:
Warnings for external use only. do not use if solution changes color or becomes cloudy. when using this product to avoid contamination, do not touch tip of container to any surface. do not reuse. once open, discard. do not touch unit dose tip to eye. stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the 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.
Do Not Use:
Warnings for external use only. do not use if solution changes color or becomes cloudy. when using this product to avoid contamination, do not touch tip of container to any surface. do not reuse. once open, discard. do not touch unit dose tip to eye. stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the 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.
When Using:
When using this product to avoid contamination, do not touch tip of container to any surface. do not reuse. once open, discard. do not touch unit dose tip to eye.
Dosage and Administration:
Directions twist and remove tab. place 1 or 2 drops in the affected eye(s) as needed for relief and discard container. if used for post-operative (e.g., lasik) dryness and discomfort, follow your eye doctor's instructions.
Stop Use:
Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.
Package Label Principal Display Panel:
Principal display panel - 32 ampule carton ndc 69183-200-32 eyes alive ⢠lubricating eye drops lubricant/carboxymethylcellulose sodium long lasting moisturizing drops to keep your eyes feeling alive! immediate relief for dry irritated eyes 32 sterile single-use containers 0.02 fl oz (0.6 ml) each made in the usa principal display panel - 32 ampule carton
Further Questions:
Questions or comments? 800.477.2884, m-f 8 am â 5 pm eastern time you can also report serious side effects to this number.