NDC 53799-401 Waldo Hydration Drops

Conium Maculatum Flowering Top, Polygala Senega Root, Ruta Graveolens Flowering Top And Sodium Chloride

NDC Product Code 53799-401

NDC CODE: 53799-401

Proprietary Name: Waldo Hydration 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: Conium Maculatum Flowering Top, Polygala Senega Root, Ruta Graveolens Flowering Top And Sodium Chloride 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 product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.

NDC Code Structure

  • 53799 - Similasan Ag

NDC 53799-401-11

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

NDC Product Information

Waldo Hydration Drops with NDC 53799-401 is a a human over the counter drug product labeled by Similasan Ag. The generic name of Waldo Hydration Drops is conium maculatum flowering top, polygala senega root, ruta graveolens flowering top and sodium chloride. The product's dosage form is liquid and is administered via ophthalmic form.

Labeler Name: Similasan Ag

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.

Waldo Hydration 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.

  • CONIUM MACULATUM FLOWERING TOP 6 [hp_X]/mL
  • SODIUM CHLORIDE 6 [hp_X]/mL
  • RUTA GRAVEOLENS FLOWERING TOP 6 [hp_X]/mL
  • POLYGALA SENEGA ROOT 6 [hp_X]/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.

  • WATER (UNII: 059QF0KO0R)
  • SILVER SULFATE (UNII: 8QG6HV4ZPO)
  • SODIUM NITRATE (UNII: 8M4L3H2ZVZ)

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: Similasan Ag
Labeler Code: 53799
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 09-29-2020 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.

Waldo Hydration 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 Ingredients

Conium maculatum 6X

Natrum muriaticum 6XPurposeburning, redness, eye strain

Ruta graveolens 6XPurposeeye strain, pressure

Senega officinalis 6XPurposeaching, dryness, eye strain, light sensitivity

Purpose

Light sensitivity, aching

Uses*

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:• tired or aching eyes• burning• redness• strained eyes (due to screen use, reading, driving)Safe for use with contact lenses.

Warnings

• For external use only.• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).• Replace cap tightly after every use.• To avoid contamination, do not touch the tip of the bottle to any surface.• To avoid contamination use within 30 days of opening. Expiration date only refers to unopened bottle.

If Pregnant, Trying To Get 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.

Do Not Use:

• if the solution changes color or becomes cloudy.

Stop Use And Ask A Doctor If:

• symptoms worsen or persist for more than 72 hours• you experience eye pain or changes in vision

Directions

For adults and children age 2 and over:• remove tamper-evident seal from neck of bottle• twist cap off bottle• DON'T squeeze bottle, squeeze plastic tip to release 2 to 3 drops into eye• apply as needed• replace cap after use

Other Information

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients

Borate buffer, Purified water, Silver sulfate (as preservative), Sodium nitrate

Questions?

Reach our customer service on hello@hiwaldo.com or 1-888-297-1269For your protection do not use if tamper evident seal around neck of bottle is missing or broken.*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

* Please review the disclaimer below.