Otc - Active Ingredient
Stannous fluoride 0.454% (0.15% w/v fluoride ion)
Natural White Sensitivity And Gum Paste, Dentifrice
FDA Label NDC 62721-0003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lornamead Products for the product Natural White Sensitivity And Gum (NDC 62721-0003). 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, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anticavity, Antigingivitis, Antihypersensitivity
- aids in the prevention of dental cavities
- helps interfere with the harmful effects of plaque associated with gingivitis
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
Otc - When Using
When using this product, if irritation occurs discontinue use.
Otc - Stop Use
Stop use and ask a dentist if:
- the problem persists or worsens. Sensitive teeths may indicate a serious problem that may need prompt care by a dentist
- pain/sensitivity still persists after 4 weeks of use
- gingivitis, bleeding, or redness persists formore that 2 weeks
- you have painful or swollen gums,pus from the gum line, loose teeth, or increasinf space between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Otc - Keep Out Of Reach Of Children
keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
adults and children 12 years of age and older: apply at least 1-inch strip of the product onto a soft bristle toothbrush
- brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
- children under 12 years of age: Consult a dentist or doctor.
Other Safety Information
Other information products containing stannous fluoride may produce surface staining of the teeth. Adequate tooth brushing may 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.
Inactive Ingredient
Inactive ingredients glycerin, water, hydrated silica pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, cellulose gum, cocamidopropyl betaine, sodium saccharin
Indications & Usage
Directions
adults and children 12 years of age and older: apply at least 1-inch strip of the product onto a soft bristle toothbrush
brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
- children under 12 years of age: Consult a dentist or doctor.
Package Label.Principal Display Panel
Nw_sensitivitygum_ctn_2011572r1 (Nw Senstivitygum Carton 2011572r1)
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