Active Ingredient
Sodium monofluorophosphate 0.76% (Total fluoride content-1000 ppm approx.)
Lucky Super Soft
FDA Label NDC 20276-553
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Delta Brands Inc for the product Lucky Super Soft (NDC 20276-553). 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 active ingredient, purpose, use, keep out of the reach of children, warnings, directions, inactive ingredients, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Use
regular brushing with fluoride tothpaste helps protect against cavities
Keep Out Of The Reach Of Children
under 6 years of age
Warnings
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately
Directions
adults and children 2 yrs 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 yrs to minimize swallowing use a pea-sized amount and brushing until good habits are established. children under 2 years: ask a dentist or physician
Inactive Ingredients
calcium carbonate, calcium hydrogen phosphate, carboxymethyl cellulose, FDC Blue 1, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, sodium lauryl sulfate, sodium saccharin, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum
Package Label
Package Label (Anticvty2pckwhtngtthpste)
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