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| Product NDC Code | 73656-019 | ||||
|---|---|---|---|---|---|
| Drug Name | White glo professional white anticavity |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| Application Number | M021 | ||||
| Labeler Name | WHITE GLO USA INC | ||||
| 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 monofluorophosphate0.76% (0.1% W/W fluoride ion). Purpose Anticavity toothpaste
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 Adults and children 2 years of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Consult a dentist or doctor. Children under 2 years of age:
| Adults and children 2 years of age & older: | Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. |
| Children under 6 years of age: | Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Calcium Carbonate, Sorbitol, Silica, Aqua (Water), Glycerin, Hydrated Silica Sodium Lauryl Sulfate, Cellulose Gum, Aroma (Flavour), Sodium Benzoate, Hydroxyethylcellulose, Sodium Phytate, Sodium Saccharin, Sodium Bicarbonate (Natural Baking Soda), Phthalimidoperoxycaproic Acid. Hydrogen Peroxide, Bromelain, Sodium Phosphate, Mica.
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.Use helps protect against cavities
Purpose
Information about the drug product’s indications for use.Purpose Anticavity toothpaste
Spl product data elements
Usually a list of ingredients in a drug product.White Glo Professional White AntiCavity SODIUM MONOFLUOROPHOSPHATE CALCIUM CARBONATE SORBITOL SILICON DIOXIDE WATER GLYCERIN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SODIUM BENZOATE HYDROXYETHYL CELLULOSE, UNSPECIFIED PHYTATE SODIUM SACCHARIN SODIUM SODIUM BICARBONATE PHTHALIMIDOPEROXYCAPROIC ACID HYDROGEN PEROXIDE BROMELAINS SODIUM PHOSPHATE MICA SODIUM FLUORIDE 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.Package Labeling: Outer Package Inner Package
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.Drug Facts
Other information • Store in a cool place, below 860 F, away from heat • Do not use if quality seal is broken or missing
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 than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. under 6 years of age.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments For customer enquiries, please contact: [email protected] White Glo USA INC. 42 West Campbell Avenue, Third Floor Campbell, California 9500. www.whiteglo.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 Keep out of reach of children If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. 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