Ocean Friends Anticavity Fluoride Bubblegum Flavor Paste, Dentifrice
FDA Label NDC 51316-163
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Ocean Friends Anticavity Fluoride Bubblegum Flavor (NDC 51316-163). 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, uses, warnings, 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
Active Ingredient
Sodium fluoride 0.243%
(Fluoride ion content 1100 ppm)
Purpose
Anticavity
Uses
helps protect against cavities.
Warnings
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.
Directions
• Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
• Do not swallow.
• Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
• Children under 2 years of age: Consult a dentist or doctor.
Inactive Ingredients
Sorbitol, Silica, Aqua, PEG-32, Xylitol, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD&C Red 40
Packaging
Image Description (51316)
* Please review the disclaimer below.
