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| Product NDC Code | 61543-1502 | ||||
|---|---|---|---|---|---|
| Drug Name | Plus white extra whitening |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 1247591 | ||||
| Application Number | part355 | ||||
| Labeler Name | CCA Industries LLC | ||||
| 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 0.83% (0.15% w/v fluoride ion)
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 and older Brush teeth thoroughly, after each meal, or at least twice a day, or as directed by a dentist or physician to minimize swallowing for children under the age of 6, use a pea size amountandsupervisebrushinguntil good habitsare established children under 2 years of ask a dentistor physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Hydrated Silica, Sorbitol, Water (Aqua), Dicalcium Phosphate, Glycerin, PVM/MA Copolymer, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Titanium Dioxide, Trisodium Phosphate, Sodium Saccharin, Blue 1
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 Aids in the removal of stains and prevention of dental decay.
Purpose
Information about the drug product’s indications for use.Purpose Anticavity whitening toothpaste
Spl product data elements
Usually a list of ingredients in a drug product.Plus White Extra Whitening SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION GLYCERIN WATER HYDRATED SILICA COPOVIDONE K25-31 TRIBASIC SODIUM PHOSPHATE SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM TITANIUM DIOXIDE SACCHARIN SODIUM SORBITOL ANHYDROUS DIBASIC CALCIUM PHOSPHATE
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.Plus White Extra Whitening -Carton 3.5 oz Plus+White Extra Whitening Fluoride Protection Fluoride Anticavity toothpaste NET WT. 3.5 oz (100G) Plus White Extra Whitening -Carton 3.5 oz
Plus White Extra Whitening -Tube 3.5 oz Plus +White Extra Whitening Fluoride Protection NET WT 3.5 oz (100G) Plus White Extra Whitening -Tube 3.5 oz
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.
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? Call Toll Free1-800-595-6230 - www.pluswhite.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 If more than used for brushing is accidentallly swallowed, get medical help or contact a Poison Control Center right away.
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