PreviDent
PreviDent 5000 PLUS
5ef93306-59dd-447b-a2ec-dd865e52c76b
HUMAN PRESCRIPTION DRUG LABEL
Mar 17, 2023
Colgate Oral Pharmaceuticals, Inc.
DUNS: 968801118
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Sodium Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
DESCRIPTION SECTION
DESCRIPTION
Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.
Active Ingredient
Sodium fluoride 1.1% (w/w).
Inactive Ingredients
water, sorbitol, hydrated silica, PEG-12, tetrapotassium pyrophosphate, sodium lauryl sulfate, flavor (Spearmint flavor only), xanthan gum, flavor (Fruitastic™ flavor only), sodium benzoate, sodium saccharin, titanium dioxide (Fruitastic™ flavor only), FD&C blue no. 1 (Spearmint flavor only), D&C red no. 33 (Fruitastic™ flavor only).
HOW SUPPLIED SECTION
HOW SUPPLIED
|
Spearmint |
Fruitastic™ | |
|---|---|---|
|
1.8 oz. (51 g) net wt. plastic tubes. |
NDC 0126-0287-66 |
NDC 0126-0286-66 |
|
Twin Pack (two 1.8 oz. (51 g) net wt. tubes) |
NDC 0126-0287-33 |
STORAGE
Store at controlled room temperature, 68-77°F (20-25°C).