NDC 49348-095 Dry Eye Relief

Glycerin, Hypromellose, Polyethylene Glycol

NDC Product Code 49348-095

NDC CODE: 49348-095

Proprietary Name: Dry Eye Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Glycerin, Hypromellose, Polyethylene Glycol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to relieve dry, irritated eyes. Common causes for dry eyes include wind, sun, heating/air conditioning, computer use/reading, and certain medications. This product may contain 1 or more of the following ingredients: carboxymethylcellulose, dextran, glycerin, hypromellose, polyethylene glycol 400 (PEG 400), polysorbate, polyvinyl alcohol, povidone, or propylene glycol, among others. Eye lubricants keep the eye moist, help to protect the eye from injury and infection, and decrease symptoms of dry eyes such as burning, itching, and feeling as if something is in the eye.

NDC Code Structure

  • 49348 - Strategic Sourcing Services Llc

NDC 49348-095-29

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 15 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Dry Eye Relief with NDC 49348-095 is a a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Dry Eye Relief is glycerin, hypromellose, polyethylene glycol. The product's dosage form is liquid and is administered via ophthalmic form.

Labeler Name: Strategic Sourcing Services Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Dry Eye Relief 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.

  • HYPROMELLOSES .2 g/100mL
  • GLYCERIN .2 g/100mL
  • POLYETHYLENE GLYCOL 400 1 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.

  • DEXTROSE (UNII: IY9XDZ35W2)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • 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: Strategic Sourcing Services Llc
Labeler Code: 49348
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: 05-01-2013 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: 12-31-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Dry Eye Relief Product Label Images

Dry Eye Relief 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 ingredientsGlycerin 0.2%Hypromellose 0.2%Polyethylene glycol 1%

Otc - Purpose

​PurposeGlycerin.....LubricantHypromellose.....LubricantPolyethylene glycol 400.....Lubricant

Indications & Usage

  • ​Usesfor the temporary relief of burning and irritation due to dryness of the eyefor protection against further irritation

Warnings

​WarningsFor external use only

Otc - Do Not Use

Do not use this product if solution changes color or becomes cloudy

Otc - Ask Doctor

  • Stop use and ask a doctor if you experienceeye painchanges in visioncontinued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours

Otc - When Using

  • When using this productto avoid contamination, do not touch tip of container to any surfacereplace cap after using. Keep container tightly closedremove contact lens before using

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIf accidentally swallowed get medical help or contact a Poison Control Center immediately

Otc - Pregnancy Or Breast Feeding

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

Dosage & Administration

  • DirectionsInstill 1 or 2 drops in the affected eye(s) as neededChildren under 6 years of age: ask doctor

Other Safety Information

Other informationRETAIN THIS CARTON FOR FUTURE REFERENCEStore at 15oC-30oC (59o-86oF)

Inactive Ingredient

​Inactive ingredientsdextrose, sodium chloride, potassium chloride, sodium phosphate monobasic, sodium phosphate dibasic, sodium bicarbonate, sodium citrate, edetate disodium, benzalkonium chloride, purified water

* Please review the disclaimer below.