NDC 47682-193 Medi-first Lubricant Eye Drops

Carboxymethylcellulose Sodium

NDC Product Code 47682-193

NDC 47682-193-83

Package Description: 30 AMPULE in 1 BOX > .4 mL in 1 AMPULE

NDC Product Information

Medi-first Lubricant Eye Drops with NDC 47682-193 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Medi-first Lubricant Eye Drops is carboxymethylcellulose sodium. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Unifirst First Aid Corporation

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.

Medi-first Lubricant Eye Drops 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.

  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM .5 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.

  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)

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.
  • 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: Unifirst First Aid Corporation
Labeler Code: 47682
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: 09-01-2020 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 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.

Medi-first Lubricant Eye Drops Product Label Images

Medi-first Lubricant Eye Drops 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

Active Ingredient

Carboxymethylcellulose sodium 0.5%

Purpose

Eye lubricant

Uses

  • For the temporary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sunfor use a protectant against further irritation

Warnings

For external use only

Otc - Do Not Use

  • Do not useif solution changes color or becomes cloudy

Otc - When Using

  • When using this productdo not reuseonce opened, discardto avoid contamination, do not touch tip of container to any surfacedo not touch unit-dose tip to eye

Otc - Stop Use

  • Stop use and aska doctor ifyou experience eye painchanges in vision occurredness or irritation of the eye continuesredness or irritation of the eye worsens or persists for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out od reach of children.If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

  • To open, twist and pull tab to removeinstill 1 or 2 drops in the affected eye(s) as needed and discard containerif used for post-operative (e.g.,LASIK) dryness and discomfort, follow your eye doctor's instructions

Other Information

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

Inactive Ingredients

Calcium chloride, **hydrochloric acid, magmesium chloride, potassium chloride, purified water, sodium chloride, **sodium hydroxide, sodium lactate** May contain these ingredients to adjust pH

Medi-First Lubricant Eye Drops Label

NDC 47682-193-83*Compare to the active ingredient in Refresh Plus®Medi-First®Preservative-freeLubricant Eye DropsCarboxymethylcellulose Sodium 0.5%Eye LubricantImmediate, long-lasting relief for dry, irritated eyesSterile30 Single-Use Containers0.01 fl oz (0.4 mL) each

* Please review the disclaimer below.