Otc - Active Ingredient
Sodium fluoride 0.24%
The following Structured Product Label (SPL) was submitted to the FDA by Rabbit Ind�stria E Com�rcio De Produtos De Higiene Pessoal Ltda for the product Dentalclean Advance Pro (NDC 84035-013). 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, warnings, otc - keep out of reach of children, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Sodium fluoride 0.24%
Anticavity
Use• Aids in the prevention of cavities • Helps prevent gingivitis •Helps interfere with harmful effects of plaque associated with
gingivitis • Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
WARNINGS:
When using this product for sensitivity
, do not use longer than 4 weeks unless recommended by a dentist.
Stop use and ask a dentist
if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
Keep out of children.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a dentist if •
gingivitis, bleeding, or redness persists for more than 2 weeks • you have painful or swollen
gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.
Keep out of reach of children
Adults and children 12 years of age and older: apply at least a 1 inch strip of the product onto a soft bristled toothbrush.
Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist.
Make sure to brush all sensitive areas of the teeth.
Do not swallow.
Children under 12 year of age: consult a dentist.
Water, Silicon Dioxide, Glycerol, Sorbitol, Sodium Lauryl Sulphate, Potassium Citrate Monohydrate, Aroma, Carmellose Sodium, Titanium Dioxide, Tetrasodium Pyrophosphate, Menthol, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose, Methyl Salicylate.
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