NDC 72265-102 Breath Mellow Water Lily

Cetylpyridinium Chloride

NDC Product Code 72265-102

NDC 72265-102-01

Package Description: 17 mL in 1 BOTTLE, SPRAY

NDC Product Information

Breath Mellow Water Lily with NDC 72265-102 is a a human over the counter drug product labeled by Curescript. The generic name of Breath Mellow Water Lily is cetylpyridinium chloride. The product's dosage form is spray and is administered via topical form.

Labeler Name: Curescript

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.

Breath Mellow Water Lily 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.

  • CETYLPYRIDINIUM CHLORIDE .0085 g/17mL

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)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Curescript
Labeler Code: 72265
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Breath Mellow Water Lily Product Label Images

Breath Mellow Water Lily 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

CETYLPYRIDINIUM CHLORIDE 0.05%

Inactive Ingredients

Water, Ethanol, Glycerin , Flavor , Xylitol , L-Menthol, Polysorbate 80 , PEG-40 Hydrogenated Castor Oil , Poloxamer 407 , Saccharin Sodium Dihydrate , Enzymatically Modified Stevia Glucosyl Stevia , Cetyl Pyridinium Chloride , Eucalyptus oil , Citric acid, Sodium Citrate, Peony root Extract, Syzygium aromaticum extract , Betula Platyphylla Japonica Bark Extract , Peppermint oil , Green tea Extract , Scutellaria Baicalensis Extract , Nasturtium Officinale Extract , Rubus Idaeus (Raspberry) Fruit Extract , Petroselinum Sativum (Parsley) Extract

Purpose

Oral Antiseptic

Warnings

■ Do not use if you are allergic to any of the ingredientsStop use and ask a dentist if ■Swelling, rash or fever develops. ■ Irritation, pain or redness persists or worsens.Keep out of the reach of children

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

■ Helps control bad breath■ aids in the removal or debris, dental plaque and control bacteria.

Directions

■ Spray directly into mouth, onto the tongue and spread thoroughly inside the mouth.■ Children 12 years and under Not for us unless directed by a healthcare professional

* Please review the disclaimer below.