Otc - Active Ingredient
Stannous fluoride 0.454% (0.14% w/v fluoride ion)
Gum And Enamel Repair Paste, Dentifrice
FDA Label NDC 69842-645
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Gum And Enamel Repair (NDC 69842-645). 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 otc - active ingredient, otc - purpose, indications & usage, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anticavity/antigingivitis
Indications & Usage
aids in the prevention of cavities * helps prevent gingivitis * helps interferre with the harmful effects of plaque associated with gingivisits * helps control plaque bacteria that contribute to the development of gingivitis
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 12 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
adults and children 12 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 * children under 12 years of age: ask a dentist
Other Safety Information
products containing stannous fluoride may produce surface staining of the teeth * adequate tooth brushing my prevent these stains which are not harmful or permanent and may be removed by your dentist * this product is specifically formulated to help prevent staining * see your dentist regularly
Inactive Ingredient
water, hydrated silica, sorbitol, sodium lauryl sulfate, carrageenan, flavor, xanthan gum, zinc citrate, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide
* Please review the disclaimer below.
