NDC 62795-4005 Reboost

Silver Nitrate, Euphorbia Resinifera Resin, Calcium Sulfide, Goldenseal, Potassium Dichromate, Luffa Operculata Fruit, Sodium Carbonate, Echinacea Unspecified, Cairina Moschata Heart/liver Autolysate And Pulsatilla Vulgaris

NDC Product Code 62795-4005

NDC Product Information

Reboost with NDC 62795-4005 is a a human over the counter drug product labeled by Medinatura. The generic name of Reboost is silver nitrate, euphorbia resinifera resin, calcium sulfide, goldenseal, potassium dichromate, luffa operculata fruit, sodium carbonate, echinacea unspecified, cairina moschata heart/liver autolysate and pulsatilla vulgaris. The product's dosage form is spray and is administered via nasal form.

Labeler Name: Medinatura

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Reboost 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.

  • SILVER NITRATE 10 [hp_X]/20mL
  • EUPHORBIA RESINIFERA RESIN 4 [hp_X]/20mL
  • CALCIUM SULFIDE 10 [hp_X]/20mL
  • GOLDENSEAL 5 [hp_X]/20mL
  • POTASSIUM DICHROMATE 6 [hp_X]/20mL
  • LUFFA OPERCULATA FRUIT 2 [hp_X]/20mL
  • SODIUM CARBONATE 6 [hp_X]/20mL
  • PULSATILLA VULGARIS 2 [hp_X]/20mL
  • CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 20 [hp_X]/20mL
  • ECHINACEA, UNSPECIFIED 3 [hp_X]/20mL

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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
  • ISOTONIC SODIUM CHLORIDE SOLUTION (UNII: VR5Y7PDT5W)
  • SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)

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.
  • 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: Medinatura
Labeler Code: 62795
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: 02-04-2020 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.

Reboost Product Label Images

Reboost 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

Anas barbariae 20X, 200C 1% *Luffa operculata 2X 1%*Pulsatilla 2X 1%*Organic Echinacea 3X 1%*Euphorbium officinarum 4X 1%*Hydrastis canadensis 5X 1%Kali bichromicum 6X 1%Natrum carbonicum 6X 1%Argentum nitricum 10X 1%*Hepar sulphuris calcareum 10X 1%

Purpose

Relieves nasal congestionRelieves  post nasal dripRelieves  sneezingRelieves sinus headache & pressureRelieves  runny noseRelieves nasal itching

Otc - Keep Out Of Reach Of Children Section

KEEP OUT OF REACH OF CHILDREN SECTION

Uses

Uses: To temporarily relieve nasal congestion.To reduce cold and flu symptoms such assinus headache & pressure.

Warnings

Warnings: Ask a doctor before use if youhave asthma. In rare cases bronchospasmmay occur in asthmatic patients. Temporaryburning, stinging, sneezing, or increasednasal discharge may occur. If pregnant orbreast-feeding, ask a health professionalbefore use. Keep out of reach of children.The use of this dispenser by more than oneperson may spread infection. If symptomspersist or worsen, a health professionalshould be consulted. Do not use if knownsensitivity to ReBoost™ or any of itsingredients exists.

Directions

Directions: Adults and children 12 yearsand older: 2 sprays into each nostril every2-4 hours. Do not exceed 24 sprays in eachnostril in 24 hours. Children 4 to 11 years:1 spray into each nostril every 2-4 hours.Do not exceed 12 sprays into each nostril in24 hours. For children under 4 years,consult your health professional.

Inactive Ingredients

Inactive Ingredients: Benzalkonium chloride,Disodium phosphate dihydrate, Isotonicsodium chloride solution, Sodium dihydrogenphosphate dihydrate

* Please review the disclaimer below.