NDC 72875-0001 Pure Mouth Liquid

Sodium Fluoride

NDC Product Code 72875-0001

NDC Product Information

Pure Mouth Liquid with NDC 72875-0001 is a a human over the counter drug product labeled by On On Co., Ltd.. The generic name of Pure Mouth Liquid is sodium fluoride. The product's dosage form is liquid and is administered via oral form.

Labeler Name: On On Co., Ltd.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Pure Mouth Liquid Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM FLUORIDE .02 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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 SODIUM SACCHARATE (UNII: 73U34YC90U)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

Additional informationCallout TooltipWhat 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.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: On On Co., Ltd.
Labeler Code: 72875
FDA Application Number: part355 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Additional informationCallout TooltipWhat 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: 02-10-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Pure Mouth Liquid Product Label Images

Pure Mouth Liquid 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

Otc - Active Ingredient

Sodium fluoride

Inactive Ingredient

Sodium fluoride

Sodium saccharin

DL-Alanine

Citric acid

Sodium citrate

Xylitol

Green extract

Licorice extract

Mugwort extract

Ginger Tincture

Sodium benzoate

l-menthol

Spearmint flavor

Purified water

Otc - Purpose

Remove bad breath, prevent tooth decay

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Use twice a day (morning and evening), use 10-15ml for one time,

take your mouth for about 30 seconds Rinse and spit out

Warnings

Keep the prescribed usage, capacity.

When using in children, please use under the guidance and supervision of the guardian.

Use only for mouthwash, do not use for internal use, guitar)

Do not use for children under 6 years old unless directed by a pharmacist or doctor.

Dosage & Administration

For oral use only

* Please review the disclaimer below.

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