Prime Tooth Care Summer Watermelon Ointment
FDA Label NDC 87053-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Tooth Care Llc for the product Prime Tooth Care Summer Watermelon (NDC 87053-007). 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 drug facts, active ingredient, purpose, use, warnings, when using this product, keep out of reach of children under 6 years of age., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium fluoride 0.25% (1100PPM)
Purpose
Anticavity
Use
helps protect against cavities
Warnings
When Using This Product
- Do not swallow
- Do not use in eye area
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 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor. • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
• Supervise children as necessary until capable of using without supervision. • Children under 2 years of age: Consult a dentist or doctor.
Inactive Ingredients
Sorbitol, Aqua, Hydrated Silica, Glycerin, Sodium Lauroyl Sarcosinate, Fragrance/ Flavor, Nano-Hydroxyapatite, Xanthan Gum, Menthol, Sodium Benzoate, Carboxymethyl Cellulose, Sodium Saccharin, Xylitol, Sodium Pyrophosphate, Red Dates Extract, Ginseng Extract, Hydrogen Peroxide (PVP - H202).
Package Labeling:
Label7 (Label7)
* Please review the disclaimer below.
