NDC 64616-041 Cold And Infection Defense

Nasal Throat Spray

NDC Product Code 64616-041

NDC 64616-041-01

Package Description: 30 mL in 1 BOTTLE, SPRAY

NDC Product Information

Cold And Infection Defense with NDC 64616-041 is a a human over the counter drug product labeled by Vitality Works, Inc. The generic name of Cold And Infection Defense is nasal throat spray. The product's dosage form is liquid and is administered via nasal form.

Labeler Name: Vitality Works, Inc

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.

Cold And Infection Defense 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.

  • ECHINACEA PURPUREA 4 [hp_X]/mL
  • ECHINACEA PURPUREA ROOT 4 [hp_X]/mL
  • BELLADONNA LEAF 5 [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 (UNII: 3M4G523W1G)
  • XYLITOL (UNII: VCQ006KQ1E)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • CITRUS PARADISI SEED (UNII: 12F08874Y7)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Nasal - Administration to the nose; administered by way of the nose.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Vitality Works, Inc
Labeler Code: 64616
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: 12-16-2003 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.

Cold And Infection Defense Product Label Images

Cold And Infection Defense 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

Cold And Infection Defense

Echinacea purpurea 4XBelladonna 5X

USP Purified Water, Collodial Silver 15 ppm, Xylitol, Sodium Chloride, Grapefruit Seed Extract, Sodium Hydroxide

If pregnant or nursing, seek advice from a health care professional. Not for use by more that 1 person. For safety finish the bottle within 60 days after opening. Keep out of reach of children.

Keep out of reach of children.

Temporary relief of symptoms associated with common cold, flu, sinusitis and sore throat.

Kee head upright, spray 1-3 times in each nostril and/or throat. Repeat 1-4 times per day as needed.

Temporary relief of syptoms associated with common cold, flu, sinusitis, and sore throat.

* Please review the disclaimer below.