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| Product NDC Code | 53045-276 | ||||
|---|---|---|---|---|---|
| Drug Name | Ionite h |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | MOUTHWASH | ||||
| RxCUI drug identifier | 583459 | ||||
| Application Number | M021 | ||||
| Labeler Name | Dharma Research, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Stannous Fluoride, 0.63%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Edetic acid, Flavor, Glycerin, Saccharin Sodium, Xylitol
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Aids in the prevention of dental decay Helps prevent gingivitis Helps interfere with harmful effects of plaque associated with gingivitis
Purpose
Information about the drug product’s indications for use.Purpose Anticavity/Antigingivitis
Spl product data elements
Usually a list of ingredients in a drug product.Ionite H Stannous Fluoride STANNOUS FLUORIDE FLUORIDE ION EDETIC ACID GLYCERIN SACCHARIN SODIUM XYLITOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Ionite H NDC 53045-276-10 PERIO MAINTENANCE ANTICAVITY/ANTIGINGIVITIS RINSE 0.63 Stannous Fluoride Concentrate with Xylitol Alcohol Free Fruit Punch IMPORTANT: Read directions for proper use. Made in USA Dye Free Gluten Free Paraben Free Home Care 10 fl. oz. (296 mL) 20150803 276 SnF2 Frt Pnch rev B
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.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.
Manufactured by Dharma Research, Inc. www.dharmaresearch.com 5220 N.W. 72 Avenue, Unit 15 Miami, FL 33166 1-877-833-3725 Reorder#: 56-00136
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not swallow.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings 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. Do not swallow.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API