Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
151177797
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Sheffield Pharmaceuticals LLC
Sheffield Pharmaceuticals LLC
151177797
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Fluoride 5000 ppm Sensitive
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
DESCRIPTION SECTION
DESCRIPTION:
Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.
SPL UNCLASSIFIED SECTION
Active Ingredients:
Sodium Fluoride 1.1% (w/w)
Potassium Nitrate 5%