NDC 69842-752 Cvs Lubricant Eye Drops Ultra

Polyethylene Glycol 400, Propylene Glycol

NDC Product Code 69842-752

NDC 69842-752-01

Package Description: 30 VIAL, SINGLE-USE in 1 CARTON > .4 mL in 1 VIAL, SINGLE-USE

NDC 69842-752-02

Package Description: 60 VIAL, SINGLE-USE in 1 CARTON > .4 mL in 1 VIAL, SINGLE-USE

NDC Product Information

Cvs Lubricant Eye Drops Ultra with NDC 69842-752 is a a human over the counter drug product labeled by Cvs. The generic name of Cvs Lubricant Eye Drops Ultra is polyethylene glycol 400, propylene glycol. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Cvs

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Cvs Lubricant Eye Drops Ultra Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PROPYLENE GLYCOL .3 g/100mL
  • POLYETHYLENE GLYCOL 400 .4 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • BORIC ACID (UNII: R57ZHV85D4)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cvs
Labeler Code: 69842
FDA Application Number: part349 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 02-12-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Cvs Lubricant Eye Drops Ultra Product Label Images

Cvs Lubricant Eye Drops Ultra Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active ingredientsPolyethylene glycol 400.........0.4%Propylene glycol ...................0.3%

Otc - Purpose

PurposesPolyethylene glycol 400......LubricantPropylene glycol.................Lubricant

Indications & Usage

  • Usefor the temporary relief of burning and irritation of the eye due to dryness of the eye

Warnings

WarningsFor external use only

Otc - Do Not Use

  • Do not useif this solution changes color or becomes cloudyif you are sensitive to any ingredient in this product

Otc - When Using

  • When using this productdo not touch tip of container to any surface to avoid contaminationreplace cap after each use

Otc - Stop Use

  • Stop use and ask a doctor ifyou feel eye painchanges in vision occurredness or irritation of the eye(s) gets worse or lasts more than 72 hours

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Dosage & Administration

  • DirectionsInstill 1 or 2 drops in the affected eye(s) as needed

Other Safety Information

  • Other informationstore at 15º-25º C (59º-77º F)use only if single-use container is intactuse before expiration date marked on containerRETAIN THIS CARTON FOR FUTURE REFERENCE

Inactive Ingredient

Inactive ingredientsboric acid, hydrochloric acid**, hypromellose, potassium chloride, purified water, sodium chloride, sodium hydroxide**** May contain these ingredients to adjust pH.

* Please review the disclaimer below.