Active Ingredient
Sodium Fluoride 0.243% (0.15% w/v fluoride ion)...Anticavity toothpaste
Western Family Complete Whitening
FDA Label NDC 55312-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Western Family Foods, Inc for the product Western Family Complete Whitening (NDC 55312-003). 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, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredients:, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Otc - Keep Out Of Reach Of Children
Indications & Usage
Helps protect against cavities.
Warnings
As with all fluoride toothpastes, 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.
Dosage & Administration
Adults and children Brush teeth throughly, preferably after
6 years and older each meal, or at least twice a day, or as
directed by your dentist. Do not swallow.
Children between To minimize swallowing, use a pea-sized
6 and 12 years amount and supervise brushing until
good habits are established.
Children under 6 years Ask a dentist or physician.
Inactive Ingredients:
Sorbitol, Silica, Water, Glycerin, Sodium Lauryl Sulfate, Zinc Citrate, Titanium Dioxide, Cellulose Gum, Flavor, PVP, Sodium Benzoate, Tetrasodium Pyrophosphate, Sodium Saccharine, Sodium Hydroxide, Carageenan, Mica, FDC Blue No.1.
* Please review the disclaimer below.
