Active Ingredient
Sodium monofluorophosphate 0.8% w/w (1000 ppm fluoride ion)
Orbitol Fluoride Whitening Toothpaste
FDA Label NDC 62685-232
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tropical Degil Cosmetics Industries Ltd for the product Orbitol Fluoride Whitening Toothpaste (NDC 62685-232). 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, do not use, when using this product, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Use
Aids in the prevention of dental cavities
Do Not Use
Do not use if you are sensitive to any of the ingredients in this prouduct.
When Using This Product
When using this product avoid contact with eyes.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children 6 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
- Children under 6 years of age: Do not use unless directed by a dentist or doctor.
Inactive Ingredients
water, sorbitol, calcium carbonate, silica, peg-32, cellulose gum, sodium lauryl sulfate, sodium bicarbonate, flavor, titanium dioxide, sodium saccharin, sodium benzoate, menthyl lactate, benzoic acid, zinc citrate, limonene
Other Information
Other information store below 30°C (86°F).
Principal Display Panel
Pdp (Ftwmf)
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