NDC 59228-105 Antiseptic Sinofresh Kool Blast Throat

Mentha Piperita

NDC Product Code 59228-105

NDC 59228-105-11

Package Description: 59.1 mL in 1 BOTTLE

NDC Product Information

Antiseptic Sinofresh Kool Blast Throat with NDC 59228-105 is a a human over the counter drug product labeled by Ems Contract Packaging. The generic name of Antiseptic Sinofresh Kool Blast Throat is mentha piperita. The product's dosage form is spray and is administered via oral form.

Labeler Name: Ems Contract Packaging

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.

Antiseptic Sinofresh Kool Blast Throat 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.

  • MENTHA PIPERITA 3 [hp_X]/100mL

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)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MENTHOL (UNII: L7T10EIP3A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XYLITOL (UNII: VCQ006KQ1E)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Ems Contract Packaging
Labeler Code: 59228
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: 09-28-2020 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.

Antiseptic Sinofresh Kool Blast Throat 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

MENTHA PIPERITA 3X

Purpose

ORAL ANTISEPTIC

Uses

  • KILLS GERMS AND BACTERIAREDUCES GERMS AND BACTERIA IN THE MOUTH AND THROAT

Warnings

  • ASK A DOCTOR BEFORE USE IF YOU HAVE:HAD ANY MEDICAL PROCEDURES FOR THE MOUTH OR THROATRAW, SCRATCHY, OR IRRITATED THROATwHEN USING THIS PRODUCT:DO NOT SPRAY IN EYES. IF CONTACT OCCURS, RINSE WITH WATERDO NOT SHARE DISPENSER WITH OTHERSSTOP USE AND ASK DOCTOR:IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR WORSENSA RASH OR IRRITATION OCCURS

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.IF MORE THAN IS USED FOR SPRAYING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY, 800-222-1222

Directions

  • ADULTS AND CHILDREN 12 YEARS AND OLDER, 3 TO 4 SPRAYS IN THE THROAT, THREE TIMES A DAY, OR AS NEEDEDCHILDREN UNDER 12 YEARS ASK A DOCTOR

Other Information

STORE AT ROOM TEMPERATURE, AWAY FROM DIRECT SUNLIGHT

Inactive Ingredients

AQUA (WATER), BENZALKONIUM CHLORIDE, CETYLPYRIDINIUM CHLORIDE, EDETATE DISODIUM, EUCALYPTUS OIL, GLYCERIN, MENTHOL, POLYSORBATE 80, SORBITOL, SUCRALOSE, XYLITOL

Questions?

888-460-4774

* Please review the disclaimer below.