NDC 53045-275 Ionite H

Stannous Fluoride

NDC Product Code 53045-275

NDC 53045-275-10

Package Description: 296 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Ionite H with NDC 53045-275 is a a human over the counter drug product labeled by Dharma Research, Inc.. The generic name of Ionite H is stannous fluoride. The product's dosage form is mouthwash and is administered via dental form.

Labeler Name: Dharma Research, Inc.

Dosage Form: Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.

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.

Ionite H 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.

  • STANNOUS FLUORIDE .63 mg/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.

  • EDETIC ACID (UNII: 9G34HU7RV0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • 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.

  • Dental - Administration to a tooth or teeth.

Product Labeler Information

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

Labeler Name: Dharma Research, Inc.
Labeler Code: 53045
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: 08-03-2015 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Ionite H 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

Stannous fluoride, 0.63%

Purpose

Anticavity/antigingivitis

Uses

  • Aids in the prevention of dental decayHelps prevent gingivitisHelps interfere with harmful effects of plaque associated with gingivitis

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age.  If more than used for rinsing is swallowed, get medical help or contact a Poison Control center right away.

Otc - Do Not Use

Do not swallow.

Directions

• Do not use before mixing with water• Adults and children 6 years of age and older:   - Use once per day after brushing your teeth with toothpaste   - Remove cap and replace with pump   - Rotate spout counter clockwise to extend   - Depress pump until rinse comes to the tip of the pump   - Pump 1/8 fl. oz. into a cup.   - Add water to the line (1 fl. oz.) on cup.   - Mix using bristle end of toothbrush   - Vigorously swish rinse between your teeth for 1 min. and then spit out.   - Do not swallow the rinse   - Do not eat or drink for 30 min. after rinsing   - Instruct children under 12 in good rinsing habits to minimize swallowing.   - Supervise children as necessary until capable of using without supervision• Children under 6: Consult a dentist or doctor

Other Information

  • Store at room temperature 59 – 86°F (15 – 30°C).This product may produce surface staining of the teeth.  Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Inactive Ingredients

Edetic acid, Flavor, Glycerin, Saccharin Sodium, Xylitol

Other

Manufactured by Dharma Research, Inc.www.dharmaresearch.com5220 N.W. 72 Avenue, Unit 15Miami, FL 331661-877-833-3725Reorder#: 56-00135

Ionite H

NDC 53045-275-10PERIO MAINTENANCE ANTICAVITY/ANTIGINGIVITIS RINSE0.63 Stannous Fluoride Concentrate with XylitolAlcohol FreeSpearmintIMPORTANT: Read directions for proper use.Made in USADye Free Gluten Free Paraben FreeHome Care10 fl. oz. (296 mL)

* Please review the disclaimer below.