Sodium Fluoride Gel
FDA Label NDC 67777-180

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Sodium Fluoride (NDC 67777-180). 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, purpose, use(s), warnings, keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Use(s)

→ Warnings

→ Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Other Information

→ Questions?

→ Label 5900

→ Label 5901

→ Label 5902

→ Label 5903

Active Ingredient

Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

Purpose

Anticavity

Use(S)

Helps protect against cavities

Warnings

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughtly after meals or at least twice a day or use as directed by a dentist or physician.

• Children under 6 years: To minimize swallowing, use a pea sized amount and supervise child's brushing and rinsing until good habits are established.

• Children under 2 years: Ask a dentist or physician.

Inactive Ingredients

Carboxymethylcellulose Sodium, Hydrated Silica, Peppermint Oil, Polyethylene Glycol 1450, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol