NDC 81488-005 Mineffect Nasal Mist

Calcarea Silicata, Silicea, Sulphur, Natrum Muriaticum, Ferrum Metallicum, Ferrum Phosphoricum, Phosphorus, Ferrum Muriaticum, Titanium Metallicum,

NDC Product Code 81488-005

NDC CODE: 81488-005

Proprietary Name: Mineffect Nasal Mist 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: Calcarea Silicata, Silicea, Sulphur, Natrum Muriaticum, Ferrum Metallicum, Ferrum Phosphoricum, Phosphorus, Ferrum Muriaticum, Titanium Metallicum, 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.
  • This medication is an iron supplement used to treat or prevent low blood levels of iron (e.g., for anemia or during pregnancy). Iron is an important mineral that the body needs to produce red blood cells and keep you in good health.

NDC Code Structure

  • 81488 - Kadesh Incoporation Co,ltd

NDC 81488-005-30

Package Description: 1 BOTTLE, SPRAY in 1 BOX > 59 mL in 1 BOTTLE, SPRAY

NDC Product Information

Mineffect Nasal Mist with NDC 81488-005 is a a human over the counter drug product labeled by Kadesh Incoporation Co,ltd. The generic name of Mineffect Nasal Mist is calcarea silicata, silicea, sulphur, natrum muriaticum, ferrum metallicum, ferrum phosphoricum, phosphorus, ferrum muriaticum, titanium metallicum, . The product's dosage form is spray and is administered via nasal form.

Labeler Name: Kadesh Incoporation Co,ltd

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.

Mineffect Nasal Mist 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.

  • CALCIUM SILICATE 5 [hp_X]/59mL
  • SILICON DIOXIDE 4 [hp_X]/59mL
  • SULFUR 4 [hp_X]/59mL
  • SODIUM CHLORIDE 4 [hp_X]/59mL
  • IRON 7 [hp_X]/59mL
  • FERROSOFERRIC PHOSPHATE 7 [hp_X]/59mL
  • PHOSPHORUS 6 [hp_X]/59mL
  • FERRIC CHLORIDE HEXAHYDRATE 7 [hp_X]/59mL
  • TITANIUM 7 [hp_X]/59mL

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.

  • POTASSIUM SILICATE (UNII: J86L1GUL6K)
  • SODIUM NITRATE (UNII: 8M4L3H2ZVZ)
  • KAOLIN (UNII: 24H4NWX5CO)
  • CEROUS OXALATE NONAHYDRATE (UNII: 0UV74P3R0J)
  • CALCIUM FLUORIDE (UNII: O3B55K4YKI)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
  • ZINC (UNII: J41CSQ7QDS)

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: Kadesh Incoporation Co,ltd
Labeler Code: 81488
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: 02-01-2021 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: 12-31-2022 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.

Mineffect Nasal Mist Product Label Images

Mineffect Nasal Mist 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 Ingredient

Calcarea Silicata 5X HPUSSilicea 4X HPUSSulphur 4X HPUSNatrum Muriaticum 4X HPUSFerrum Metallicum 7X HPUSFerrum Phosphoricum 7X HPUSPhosphorus 6X HPUSFerrum Muriaticum 7X HPUSTitanium Metallicum 7X HPUSThe letters HPUS indicate that this ingredients is officially included in the Homeopathic pharmacopoeia of the United States.

Purpose

Irritated nasal passageBlocked nose due to sinus inflammationAllergic rhinitisAllergy symptomsUpper respiratoryCommon cold, blocked noseNose blockageRespiratory allergiesInflammation of the mucus membrane

Uses

• Temporary relief of sinus inflammation of the nasal passages• Temporary relief of sore throat caused by upper respiratory allergies and infections• Soothe irritated nasal passages and alleviate the pains of the sinuses• Helps cleanse nasal passages and promotes fast acting flu symptom fighting effect• Recommended for repeated use

Directions

• With nose slightly raised, pump sprayer into each nostril• Use Puriton Nasal Mist as often as needed. It is intended to daily use• Use at the first sign of flu and cold• Use to moisturize and protect delicate sinus tissues

Warning

When using this product *replace cap after usingStop use and ask a doctor *If condition worsens *If condition last more than 7 days or clear up and occur again within a few daysIf pregnant or breast-feeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of Children

Other Information

*You may experience a burning sensation. It is normal as Puriton Nasal Mist takes effect

Inactive Ingredients

Kali Silicatum, Natrum Nitricum, Alumina Silicata, Cerium Oxalicum, Calcarea Fluorica, Alumina, Magnesia Muriatica, Magnesia Sulphurica, Zincum Metallicum

* Please review the disclaimer below.