Label: MAXIMUM SECURITY- sodium fluoride gel, dentifrice
-
NDC Code(s):
53247-132-01,
53247-132-02,
53247-132-03,
53247-132-04, view more53247-132-05
- Packager: Bob Barker Company Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 18, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- Use
- Warnings
-
Directions
Adults & Children 6 years of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing). Children under 2 years: Ask a dentist or physician. - Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 17 g Tube Label
-
INGREDIENTS AND APPEARANCE
MAXIMUM SECURITY
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53247-132 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride 2.2 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Sodium Lauryl Sulfate (UNII: 368GB5141J) Sodium Hydroxide (UNII: 55X04QC32I) SACCHARIN SODIUM (UNII: SB8ZUX40TY) EDETATE DISODIUM (UNII: 7FLD91C86K) Sodium Benzoate (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53247-132-01 4.3 g in 1 PACKET; Type 0: Not a Combination Product 01/01/2008 2 NDC:53247-132-02 17 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2008 3 NDC:53247-132-03 24 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2008 4 NDC:53247-132-04 43 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2008 5 NDC:53247-132-05 130 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M021 01/01/2008 Labeler - Bob Barker Company Inc. (058525536)