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| Product NDC Code | 81275-010 | ||||
|---|---|---|---|---|---|
| Drug Name | Rorobell wawa tooth |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 2471311 | ||||
| Application Number | part355 | ||||
| Labeler Name | ROROBELL | ||||
| 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 0.72%
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 INGREDIENTS Calcium Carbonate, Dicalcium Phosphate Dihydrate, Aluminium Chlorohydrate, Sorbitol, Water, Glycerin, Sodium Cocoyl Glutamate, Cellulose Gum, Thymus quinquecostatus Flavor, Menthol, Xylitol, Erythritol, Mentha Piperita (Peppermint) Oil, Hydroxyapatite, Sodium Copper Chlorophyllin, Allyl Isothiocyanate, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Aloe Barbadensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Citrus Grandis (Grapefruit) Fruit Extract, Taraxacum Officinale (Dandelion) Rhizome, Pistacia Lentiscus (Mastic) Gum
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 teeth white and strong. ■ Keep your mouth clean. ■ Refresh the inside of the mouth. ■ Prevents tooth decay caused by fluoride and removes bad breath. ■ Increases aesthetic effect. ■ Prevention of gingivitis and periodontitis (alveolar fistula) ■ Prevention of periodontal disease ■ Prevention of gum disease ■ 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.Rorobell WaWa Tooth Sodium Monofluorophosphate Sodium Monofluorophosphate FLUORIDE ION Calcium Carbonate DIBASIC CALCIUM PHOSPHATE DIHYDRATE ALUMINUM CHLOROHYDRATE
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.PACKAGE LABEL (Tube) NDC: 81275-010-01 Image of tube
PACKAGE LABEL (Carton) NDC: 81275-010-02 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℃)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS 02-515-0529 www.rorobell.com
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 950ppm 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