Active Ingredients
Sodium monofluorphosphate 1.15% (1500 ppm/ 0.15% w/v fluoride ion)
Zohar Toothpaste
FDA Label NDC 55754-122
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Broom Lane Enterprises for the product Zohar Toothpaste (NDC 55754-122). 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 ingredients, purpose, uses, otc - keep out of reach of children, directions, inactive ingredient, questions?, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Uses
Aids in the prevention of dental cavities
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
- do not swallow
- supervise children as necessary until capable of using without supervision.
| adults and children 6 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. |
| children 6 to 12 years | instruct in good brushing and rinsing habits(to minimise swallowing) |
| children under 6 years | do not use unless directed by dentist or doctor |
Inactive Ingredient
Calcium Carbonate, Water, Glycerine, Hydrated Silica, Sodium Lauryl Sulphate, Silica, Cellulose gum, Flavour, Carvone, Sodium Saccharin, Methylparaben, Limonene
Questions?
call 718 256 9100
you may also report serious side effects to this phone number
Principal Display Panel
Zohar
FLUORIDE
TOOTHPASTE
COOL MINT
HELPS FIGHT TOOTH DECAY
Net Wt. 4oz/75ml
* Please review the disclaimer below.
