NDC 72151-602 Pepteron

Homeopathic Nasal Spray

NDC Product Code 72151-602

NDC 72151-602-05

Package Description: 5 mL in 1 BOTTLE

NDC Product Information

Pepteron with NDC 72151-602 is a a human over the counter drug product labeled by Maitland Labs Of Central Florida. The generic name of Pepteron is homeopathic nasal spray. The product's dosage form is spray, metered and is administered via nasal form.

Labeler Name: Maitland Labs Of Central Florida

Dosage Form: Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.

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.

Pepteron 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.

  • NAJA NAJA WHOLE 4 [hp_X]/.2mL
  • MAGNESIUM CHLORIDE 2 [hp_X]/.2mL
  • SCOPOLAMINE HYDROBROMIDE 6 [hp_X]/.2mL
  • SULFUROUS ACID 7 [hp_X]/.2mL

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)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)

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: Maitland Labs Of Central Florida
Labeler Code: 72151
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: 03-26-2020 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Pepteron Product Label Images

Pepteron 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 Per Dose Purpose

Contains cobra venom 4X HPUS analgesic, anti-inflammatoryContains magnesium chloride 2X HPUS cold remedyContains scopolamine hydrobromide 6X HPUS feverContains sulphurous acid 7X HPUS cold and flu remedyReference :the Homeopathic Pharmacopoeia of the United States (HPUS)Contains 25 doses

Warning

  • If symptoms persist or worsen, discontinue use, seek medical attentionAvoid contact with eyes. If product gets into eyes,flush with water, seek medical attentionIf pregnant or breastfeeding ask a health professional before useConsult a medical professional if using other medications for known interactionsThe use of this dispenser by more than one person may spread infection.keep out of reach of children.

Purpose

Temporarily relieves symptoms associated with colds and flu,including headache, fever, rhinitis and sore throat.

Indication

Temporarily relieves symptoms associated with colds and flu,including headache, fever, rhinitis and sore throat.

Directions For Use

  • •   Do not use if tamperproof cover is missing •   Press down 4 times to prime the pump.spray once in to each nostril.Use 2 times per day to relieve discomfort.

Inactive Ingredient Section

Benzalkonium chloride NF, purified water, sodium phosphate,monobasics USP

* Please review the disclaimer below.