Western Family Whitening
FDA Label NDC 55312-162

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 Whitening (NDC 55312-162). 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.

Active Ingredient

Sodium Fluoride 0.243% (0.15% w/v fluoride ion)...Anticavity toothpaste

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
2 years and older               each meal, or at least twice a day, or as
                                            directed by your dentist.  Do not swallow.

Children under                   To minimize swallowing, use a pea-sized
6 years of age                    amount and supervise brushing until
                                            good habits are established.

Children under 2 years       Ask a dentist or physician.


Inactive Ingredients:

Sorbitol, Silica, Water, PEG-6, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Titanium Dioxide, Sodium Phosphate, Sodium Saccharine

Principal Display Panel

Image Of Container (Wfwhitening)

Image Of Container (Wfwhitening)

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