NDC 73024-399 Optimel Manuka Dry Eye Drops


NDC Product Code 73024-399

NDC Code: 73024-399

Proprietary Name: Optimel Manuka Dry Eye Drops 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 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.

NDC Code Structure

  • 73024 - Melcare Biomedical Pty Ltd
    • 73024-399 - Optimel Manuka Dry Eye Drops

NDC 73024-399-10

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 10 mL in 1 BOTTLE, DROPPER

NDC Product Information

Optimel Manuka Dry Eye Drops with NDC 73024-399 is a a human over the counter drug product labeled by Melcare Biomedical Pty Ltd. The generic name of Optimel Manuka Dry Eye Drops is glycerin. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Melcare Biomedical Pty Ltd

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

Optimel Manuka Dry 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.

  • GLYCERIN 2 mg/mL

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.

  • HONEY (UNII: Y9H1V576FH)
  • 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: Melcare Biomedical Pty Ltd
Labeler Code: 73024
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: 07-19-2019 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: 12-31-2020 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.

Optimel Manuka Dry Eye Drops Product Label Images

Optimel Manuka Dry 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


Drug Facts

Active Ingredients

Glycerin 0.2%




  • For the temporary relief of burning and irritation due to dryness of the eye. for use as a protectant against further irritation or to relieve dryness of the eye.


For external use only

Do Not Use

  • If you have a history of hypersensitivity or sensitive to honey or benzoate preservatives without seeking medical advice.if solution changes color or becomes cloudy.if packaging is damaged.serious conditions should be managed under the supervision of a doctor.

When Using This Product

  • Before first use: check tamper ring is attached to cap base – remove cap and discard ring.to avoid contamination, do not touch tip of container to any surface.replace cap after using.remove contact lenses before using.wait at least 10 minutes before contact lens insertion.Initial stinging and redness on drop application is to be expected.

Stop Use And Ask A Doctor If

  • You experience eye pain change in vision, continued redness or irritation of the eye.Condition worsens

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


  • Wash hands.Instill 1 drop to the inner corner of the affected of the affected eye up to 3 times daily.Children under 16 years of age ask a doctor.

Other Information

  • Single patient use only.Discard 2 months after opening.Store below 25°C (77°F).

Inactive Ingredients

Honey (
Leptospermum spp.), Sodium benzoate, Sodium chloride, Water.


Web: www.melcare.com

Email: info@melcare.com

Phone: 8557082611

* Please review the disclaimer below.

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