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DRUG FACTS:
Dist. by Bob Barker Co. Inc. Fuquay-Varina, NC 27526
Meridian Anticavity Fluoride Paste, Dentifrice
FDA Label NDC 53247-146
8 label sections · Submitted to the FDA by Bob Barker Company Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bob Barker Company Inc. for the product Meridian Anticavity Fluoride (NDC 53247-146). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, otc - keep out of reach of children, directions, inactive ingredients, principal display panel - 24 grams tube label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium Monofluorophosphate…..0.76% (0.1% w/v fluoride ion)
Purpose
Anticavity toothpaste
Use
Helps protect against cavities.
Otc - Keep Out Of Reach Of Children
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 immediately.
Directions
| Adults & Children 6 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 2 to 6 years: | Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing). |
| Children under 2 years: | Ask a dentist or physician. |
Inactive Ingredients
Calcium Carbonate, Sorbitol, Water, Sodium Lauryl Sulfate, Silica, Glycerin, Cellulose Gum, Benzalkonium Chloride, Flavor, Sodium Saccharin, PEG 400, Sodium Chloride, Sodium Methylparaben, Menthol, Sodium Propylparaben
Principal Display Panel - 24 Grams Tube Label
meridian™
fresh mint flavor
anticavity fluoride toothpaste
NET WT 0.85 OZ (24 GRAMS)
Principal Display Panel (24 GRAMS Tube Label)
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