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| Product NDC Code | 72326-8002 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Plak smacker anti cavity fluoride |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | DENTAL | ||||||||
| Dosage Form | PASTE | ||||||||
| RxCUI drug identifier | 416783 | ||||||||
| Application Number | M021 | ||||||||
| Labeler Name | YOUNG PS ACQUISITION, 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 Fluoride 0.24% (0.14% w/v 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 and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. Do not swallow To minimize swallowing use a pea sized amount in children under 6 years. Supervise children's brushing until good habits are established. Children under 2 years of age, consult a dentist or physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Sorbitol, Water, Hydrated silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propyparaben, Blue1, Red 33
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 prevention of dental cavities.
Purpose
Information about the drug product’s indications for use.Purpose Anticavity toothpaste
Purpose Anti-Cavity Toothpaste
Spl product data elements
Usually a list of ingredients in a drug product.Plak Smacker Anti Cavity Fluoride Sodium Fluoride POLYETHYLENE GLYCOL 1450 HYDRATED SILICA SACCHARIN SODIUM WATER SODIUM LAURYL SULFATE SORBITOL SODIUM FLUORIDE FLUORIDE ION POLYETHYLENE GLYCOL 300 CARBOXYMETHYLCELLULOSE PROPYLPARABEN METHYLPARABEN FD&C BLUE NO. 1 D&C RED NO. 33
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.PLAK SMACKER® NO SUGAR ADDED DINOSAUR BUBBLE GUM FLAVOR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE NET WT. 4.2 oz (119g) Dinosaur_image.jpg Dinosaur_small_image.jpg
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 use if inner foil is torn, cut 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.
Keep out of the reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.
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? (800) 558-6684
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 the reach of children under 6 years of age .If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if inner foil is torn, cut, or missing. Keep out of reach of children.
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