The following Structured Product Label (SPL) was submitted to the FDA by Tropical International Manufacturing Inc for the product Dental Plus Whitening (NDC 62678-216). 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 other, active ingredient, purpose, use, warnings, directions, inactive ingredients, questions? comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Drug Facts (continued)
Dental plus Whitening 172g
Made by Tropical Degil Cosmetics
Ind. Ltd. Kiryat Shmona, Israel for
Tropical International Cosmetics, Inc.
18 Stewart Street,
Brooklyn, NY 11207 USA
Made in Israel
For best results, squeeze tube from
the bottom and flatten as you go up
Sodium Monofluorophosphate 0.8% (1,000 ppmF)
anticavity
For cavity prevention, Tooth Protection and Whiter Teeth.
Keep out of the 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.
| Adults and children 2 years of age and older Children 2 to 6 years Children under 2 years | Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by dentist or physician. Use only a pea-sized amount and supervise child brushing and rinsing (to minimize swallowing) Ask a dentist or a physician |
Water, Sorbitol, Calcium Carbonate, Silica, PEG-32, Sodium Lauryl Sulphate, Cellulose Gum, Sodium Bicarbonate, Flavor, Titanium Dioxide, Sodium Saccharin, Sodium Benzoate, Zinc Citrate
call toll-free 1-888-777-8767. Monday-Friday 9am-5pm
ANTICAVITY FLUORIDE TOOTHPASTE
Tropical DEGIL Dental plus Whitening
FOR HEALTHY AND BRIGHT TEETH
NET WT.6 OZ (172 G) Cont. Neto: 6 oz (172 G)
Principal Display Panel (6 oz Tube)
* Please review the disclaimer below.
