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Freshenup Fluoride Fresh Mint
FDA Label NDC 52553-050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by U. S. Nonwovens Corp for the product Freshenup Fluoride Fresh Mint (NDC 52553-050). 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, keep out of the reach of children, directions, inactive ingredients, principal display panel, 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% (Total Fluoride Content - 1000 ppm approx)
Purpose
Anticavity
Use
regular brushing with fluoride toothpaste helps protect teeth against cavities
Keep Out Of The Reach Of Children
Keep out of the reach of children under 6 years of age. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.
Directions
| adults and children 2 years and older | brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician |
| children under 6 years | to minimize swallowing use a pea sized amount and supervise brushing until good habits are established |
| children under 2 years | ask a dentist or physician |
Inactive Ingredients
Calcium Carbonate, Sorbitol, Aqua, Silica, Sodium Lauryl Sulphate, Flavour, Sodium Silicate, Tetra Sodium Pyrophosphate, Cellulose Gum, Xanthan Gum, Benzyl Alcohol, Sodium Saccharin, Sodium Benzoate, Tetra Potassium Pyrophosphate
Principal Display Panel
NDC 52553-050-02
ANTICAVITY
Freshenup
FLUORIDE TOOTHPASTE
FRESH MINT
SENSITIVE + GENTLE
TARTAR + GUM HEALTH
Fight Gengivitis
Plaque ShieldTM
Aid in Breath Control
NET WT 3.5 OZ (99.2 g)
Label (50)
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