Good Sense Lubricating Plus
Carboxymethylcellulose Sodium
L. Perrigo Company
Human Otc Drug
NDC 0113-0323Good Sense Lubricating Plus also known as Carboxymethylcellulose Sodium is a human otc drug labeled by 'L. Perrigo Company'. National Drug Code (NDC) number for Good Sense Lubricating Plus is 0113-0323. This drug is available in dosage form of Solution, Gel Forming / Drops. The names of the active, medicinal ingredients in Good Sense Lubricating Plus drug includes Carboxymethylcellulose Sodium - .5 g/100mL . The currest status of Good Sense Lubricating Plus drug is Active.
Drug Information:
| Drug NDC: | 0113-0323 |
| 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: | Good Sense Lubricating Plus |
| 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: | Carboxymethylcellulose Sodium |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | L. Perrigo Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution, Gel Forming / Drops |
| 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 - .5 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| 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: | 11 Nov, 2013 |
| 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: | L. Perrigo Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 |
|---|
| 0113-0323-65 | 6 POUCH in 1 CARTON (0113-0323-65) / 5 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE | 11 Nov, 2013 | 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:
Good sense lubricating plus carboxymethylcellulose sodium carboxymethylcellulose sodium carboxymethylcellulose calcium chloride magnesium chloride potassium chloride sodium chloride sodium lactate water sodium hydroxide hydrochloric acid
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
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 opened, discard ⢠do not touch unit-dose tip to eye stop use and ask a doctor if ⢠you experience eye pain ⢠changes in vision occur ⢠redness or irritation of the eye continues ⢠redness or irritation of the eye 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 (1-800-222-1222).
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 opened, discard ⢠do not touch unit-dose tip to eye stop use and ask a doctor if ⢠you experience eye pain ⢠changes in vision occur ⢠redness or irritation of the eye continues ⢠redness or irritation of the eye 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 (1-800-222-1222).
When Using:
When using this product to avoid contamination ⢠do not touch tip of container to any surface ⢠do not reuse ⢠once opened, discard ⢠do not touch unit-dose tip to eye
Dosage and Administration:
Directions ⢠to open, twist and pull tab to remove ⢠instill 1 or 2 drops in the affected eye(s) as needed and discard container
Stop Use:
Stop use and ask a doctor if ⢠you experience eye pain ⢠changes in vision occur ⢠redness or irritation of the eye continues ⢠redness or irritation of the eye worsens or persists for more than 72 hours
Package Label Principal Display Panel:
Package/label principal display panel sterile lubricating plus lubricant eye drops carboxymethylcellulose sodium 0.5% moisturizing relief immediate, soothing relief for dry eyes preservative-free actual size compare to active ingredient of refresh plus ® lubricant eye drops 100% satisfaction guaranteed 30 sterile single-use containers 0.01 fl oz (0.4 ml) each lubricating plus image
Further Questions:
Questions or comments? 1-800-719-9260