NDC 69491-215 Delta Ron 2019 Amenity With Colgate Cavity Protection

Sodium Monofluorophosphate, Aluminum Zirconium Tetrachlorohydrex Gly

NDC Product Code 69491-215

NDC Code: 69491-215

Proprietary Name: Delta Ron 2019 Amenity With Colgate Cavity Protection 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: Sodium Monofluorophosphate, Aluminum Zirconium Tetrachlorohydrex Gly 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

  • 69491 - Buzz Export Services Pty., Ltd.
    • 69491-215 - Delta Ron 2019 Amenity With Colgate Cavity Protection

NDC 69491-215-00

Package Description: 1 KIT in 1 KIT * 10 g in 1 TUBE (42555-060-45) * 14 g in 1 TUBE (64942-1343-2)

NDC Product Information

Delta Ron 2019 Amenity With Colgate Cavity Protection with NDC 69491-215 is a a human over the counter drug product labeled by Buzz Export Services Pty., Ltd.. The generic name of Delta Ron 2019 Amenity With Colgate Cavity Protection is sodium monofluorophosphate, aluminum zirconium tetrachlorohydrex gly. The product's dosage form is kit and is administered via form.

Labeler Name: Buzz Export Services Pty., Ltd.

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • PPG-14 BUTYL ETHER (UNII: R199TJT95T)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • STEARETH-100 (UNII: 4OH5W9UM87)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)

Product Labeler Information

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

Labeler Name: Buzz Export Services Pty., Ltd.
Labeler Code: 69491
FDA Application Number: part355 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 04-01-2019 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: 12-31-2020 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.

Delta Ron 2019 Amenity With Colgate Cavity Protection Product Label Images

Delta Ron 2019 Amenity With Colgate Cavity Protection 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

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Aluminum Zirconium Tetrachlorohydrex GLY (15.2%)

Purpose

Anticavity

Anti-perspirant

Use

Helps protect against cavities

Keep Out Of The Reach Of Children Under 6 Years Of Age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years  use only apea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician

Apply to underarms only

Inactive Ingredients

Dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Cyclopentasiloxane, Stearyl Alcohol, C12-15 Alkyl Benzoate, PPG-14 Butyl Ether, Hydrogenated Castor Oil, PEG-8, Fragrance (Parfum), Dimethicone, Silica, Polyethylene, Helianthus Annuus (Sunflower) Seed Oil, Steareth-100, BHT, Hydroxyethyl Urea

Uses

  • Reduces Underarm Wetness48 Hour Protection

Warnings

For external use only

Do Not Use

On broken skin

Ask A Doctor Before Use

If you have kidney disease.

Stop Use

If rash or irritation occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

* Please review the disclaimer below.

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