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| Product NDC Code | 78151-040 | ||||
|---|---|---|---|---|---|
| Drug Name | Karl and hans botanic double mint |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 1737795 | ||||
| Application Number | M021 | ||||
| Labeler Name | PIGEON CORPORATION | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Sodium Monofluorophosphate 0.74%
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 ■ Brushing the teeth with a suitable amount
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT D-Sorbitol Solution, Concentrated Glycerin, Water, Silicon Dioxide, Sodium Lauryl Sulfate, Xylitol, Double Mint Flavor, Sodium Carboxymethylcellulose, Sodium Chloride, Double Mint Flavor, Titanium Oxide, Peppermint Oil, Aluminium Chlorohydroxy Allantoinate, Enzymatically Modified Stevia, Hydroxyapatite, L-Menthol, Propolis Extract10, Matricaria Extract, Green Tea Extract, Aloe Extract, Rosemary Extract, Grapefruit Extract, Houttuynia Cordata Extract, Sage Extract
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 ■ Keep your mouth clean. ■ Prevents tooth decay caused by fluoride and removes bad breath. ■ Increases aesthetic effect. ■ Prevention of plaque deposition, removal of plaque (anti-prag)
Purpose
Information about the drug product’s indications for use.PURPOSE Caries prevention
Spl product data elements
Usually a list of ingredients in a drug product.Karl and Hans Botanic Double Mint Sodium Monofluorophosphate SORBITOL GLYCERIN WATER SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION
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.Image of carton
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 ■ Keep out of the reach of children under 6 years of age.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ Airtight container, Store in normal temperature (1~30℃)
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 ■ Contains 977ppm of fluoride. ■ Do not swallow and rinse mouth thoroughly after use ■ If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor. ■ For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing. ■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities. ■ Keep out of the reach of children under 6 years of age.
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