NDC 73563-022 Aqua Blue Mouthwash

Methyl Salicylate, Menthol, Unspecified Form, Eucalyptol, And Thymol

NDC Product Code 73563-022

NDC CODE: 73563-022

Proprietary Name: Aqua Blue Mouthwash 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: Methyl Salicylate, Menthol, Unspecified Form, Eucalyptol, And Thymol 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.

NDC Code Structure

  • 73563 - Body One Products Inc

NDC 73563-022-01

Package Description: 3785 mL in 1 JUG

NDC Product Information

Aqua Blue Mouthwash with NDC 73563-022 is a a human over the counter drug product labeled by Body One Products Inc. The generic name of Aqua Blue Mouthwash is methyl salicylate, menthol, unspecified form, eucalyptol, and thymol. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Body One Products Inc

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 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.

Aqua Blue Mouthwash 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.

  • METHYL SALICYLATE .6 mg/mL
  • MENTHOL, UNSPECIFIED FORM .42 mg/mL
  • EUCALYPTOL .92 mg/mL
  • THYMOL .64 mg/mL

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)
  • SORBITOL (UNII: 506T60A25R)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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: Body One Products Inc
Labeler Code: 73563
FDA Application Number: part356 What 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 02-01-2020 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.

Aqua Blue Mouthwash Product Label Images

Aqua Blue Mouthwash 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

Other

Drug Facts

Otc - Purpose

Active ingredientPurposeEucalyptol 0.092%Antiplaque/AntigingivitisMenthol 0.042%Antiplaque/AntigingivitisMethyl Salicylate 0.060%Antiplaque/AntigingivitisThymol 0.064%Antiplaque/Antigingivitis

Use

Helps control plaque that leads to gingivitis

Otc - Do Not Use

Do not use if you have painful or swollen gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontis, a serious form of gum disease.

Otc - Stop Use

Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Do not swallownot intended to replace brushing or flossing.Adults and children 12 years of age and olderVigorously swish 20mL between teeth twice a day for 30 seconds then spit out.children under 12 years of ageconsult a dentist or doctor

Other Information

Store at room temperature (59°-77°F).

Inactive Ingredients

Water,Alcohol (21.6%),Polysorbate 80,Sorbitol,Flavor,Benzoic Acid,Sodium Saccharin,Sodium Benzoate,Blue 1,Yellow 5

* Please review the disclaimer below.