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| Product NDC Code | 53045-271 | ||||
|---|---|---|---|---|---|
| Drug Name | Ionite h |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL, DENTIFRICE | ||||
| RxCUI drug identifier | 237847 | ||||
| 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, 0.4%
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 • This is not a toothpaste. Read directions carefully before using. • Adults and children 6 years of age and older: o Use once per day after brushing teeth thoroughly with toothpaste o Twist off cap to remove foil seal o Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces. o Allow the gel to remain on your teeth for 1 minute o Spit out. Do not swallow o Do not eat, drink, or rinse for at least 30 minutes • Children under 6: consult a dentist or doctors
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Carbopol, citric acid, flavor, glycerin, sodium hydroxide, water, 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 cavities (caries).
Purpose
Information about the drug product’s indications for use.Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Ionite H Stannous Fluoride STANNOUS FLUORIDE FLUORIDE ION CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) CITRIC ACID MONOHYDRATE GLYCERIN SODIUM HYDROXIDE WATER 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 53045-271-04 Home Care 0.4% Stannous Fluoride Gel with Xylitol Anticavity Fluoride Preventative Treatment Gel Bubble Gum Made in USA Gluten Free Dye Free Reorder#: 56-00131 4.3 oz. (122 g) 20150802 271 SnF2 BubGm revB
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
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. If more that used for brushing is accidentally 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. If more that used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not swallow. Supervision of children is required when using this product. Developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed.
Supervision of children is required when using this product. Developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed.
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