Visine Red Eye Hydrating Comfort Eye Drops
Tetrahydrozoline Hydrochloride And Polyethylene Glycol 400
Johnson & Johnson Consumer Inc.
Human Otc Drug
NDC 69968-0356Visine Red Eye Hydrating Comfort Eye Drops also known as Tetrahydrozoline Hydrochloride And Polyethylene Glycol 400 is a human otc drug labeled by 'Johnson & Johnson Consumer Inc.'. National Drug Code (NDC) number for Visine Red Eye Hydrating Comfort Eye Drops is 69968-0356. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Visine Red Eye Hydrating Comfort Eye Drops drug includes Polyethylene Glycol 400 - 10 mg/mL Tetrahydrozoline Hydrochloride - .5 mg/mL . The currest status of Visine Red Eye Hydrating Comfort Eye Drops drug is Active.
Drug Information:
| Drug NDC: | 69968-0356 |
| 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: | Visine Red Eye Hydrating Comfort Eye Drops |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Visine Red Eye Hydrating Comfort |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Eye Drops |
| 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: | Tetrahydrozoline Hydrochloride And Polyethylene Glycol 400 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Johnson & Johnson Consumer Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ 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: | POLYETHYLENE GLYCOL 400 - 10 mg/mL
TETRAHYDROZOLINE HYDROCHLORIDE - .5 mg/mL
|
| 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: | 27 Apr, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| 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, 2024 |
| 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: | Johnson & Johnson Consumer Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 996209
|
| 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: | B697894SGQ
0YZT43HS7D
|
| 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 |
|---|
| 69968-0356-1 | 700 BOTTLE, DROPPER in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (69968-0356-1) / 8 mL in 1 BOTTLE, DROPPER | 27 Apr, 2020 | N/A | No |
| 69968-0356-2 | 1 BOTTLE, DROPPER in 1 CARTON (69968-0356-2) / 15 mL in 1 BOTTLE, DROPPER | 27 Apr, 2020 | N/A | No |
| 69968-0356-3 | 1 BOTTLE, DROPPER in 1 CARTON (69968-0356-3) / 8 mL in 1 BOTTLE, DROPPER | 27 Apr, 2020 | N/A | No |
| 69968-0356-4 | 1 BOTTLE, DROPPER in 1 BLISTER PACK (69968-0356-4) / 8 mL in 1 BOTTLE, DROPPER | 27 Apr, 2020 | 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 1% lubricant tetrahydrozoline hcl 0.05% redness reliever
Product Elements:
Visine red eye hydrating comfort eye drops tetrahydrozoline hydrochloride and polyethylene glycol 400 ascorbic acid boric acid dextrose, unspecified form glycerin glycine hypromellose, unspecified magnesium chloride polixetonium chloride potassium chloride water sodium citrate, unspecified form sodium lactate sodium phosphate, dibasic, anhydrous tetrahydrozoline hydrochloride tetrahydrozoline polyethylene glycol 400 polyethylene glycol 400
Indications and Usage:
Uses for the relief of redness of the eye due to minor eye irritations for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun for use as a protectant against further irritation or to relieve dryness of the eye
Warnings:
Warnings for external use only ask a doctor before use if you have narrow angle glaucoma. when using this product pupils may become enlarged temporarily overuse may cause more eye redness remove contact lenses before using do not use if this solution changes color or becomes cloudy do not touch tip of container to any surface to avoid contamination replace cap after each use stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eye lasts condition worsens or lasts more than 72 hours if pregnant or breast-feeding, ask a health professional before use. 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 pupils may become enlarged temporarily overuse may cause more eye redness remove contact lenses before using do not use if this solution changes color or becomes cloudy do not touch tip of container to any surface to avoid contamination replace cap after each use
Dosage and Administration:
Directions adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a day children under 6 years of age: consult a doctor children under 2 years of age: do not use
Stop Use:
Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eye lasts condition worsens or lasts more than 72 hours
Package Label Principal Display Panel:
Principal display panel - 15 ml bottle carton visine ® red eye hydrating comfort lubricant/redness reliever eye drops works in 30 seconds redness + irritation relief lubricates + refreshes sterile 1/2 fl oz (15ml) principal display panel - 15 ml bottle carton
Further Questions:
Questions? call toll-free 888-734-7648 or 215-273-8755 (collect)