Label: JUST RIGHT 5000- 1.1% sodium fluoride toothpaste gel, dentifrice
- NDC Code(s): 57511-0120-9
- Packager: Elevate Oral Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 12, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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OTC - ACTIVE INGREDIENT SECTION
Sodium Fluoride 1.1% Anticavity toothpaste
INDICATIONS & USAGE SECTION
helps protect against cavities
WARNINGS SECTION
Keep out of reach of children under 6 years of age: if more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children under 6 years of age:
INSTRUCTIONS FOR USE SECTION
Directions: *adults and children 2 years and older: wet a toothbrush and pump once to apply a pea-sized (~0.25 gram) amount of toothpaste onto a toothbrush * brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. * to minimize swallowing, only pump once to dispense a pea-sized amount for children under 6 years. * supervise children's brushing untill good habits are established. * children under 2 years: ask dentist or physician.
INACTIVE INGREDIENT SECTION
Inactive ingredients; Sorbitol, Water, Glycerin, Hydrated silica, PEG-8, Bubble Gum/Mint Flavor, Sodium Lauryl Sulfate, Xanthan Gum, Potassium Phosphate, Sodium Benzoate, Sodium Saccharin, Mica, Blue 1.1% Solution
OTC - QUESTIONS SECTION Questions? 1-877-866-9113 or visit our website at www.elevateoralcare.com
OTC - PURPOSE SECTION Helps protect against Cavities
DOSAGE & ADMINISTRATION SECTION Directions: *adults and children 2 years and older: wet a toothbrush and pump once to apply a pea-sized (~0.25 gram) amount of toothpaste onto a toothbrush * brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. * to minimize swallowing, only pump once to dispense a pea-sized amount for children under 6 years. * supervise children's brushing untill good habits are established. * children under 2 years: ask dentist or physician.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JUST RIGHT 5000
1.1% sodium fluoride toothpaste gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57511-0120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 1.1 g in 100 g Inactive Ingredients Ingredient Name Strength XYLITOL (UNII: VCQ006KQ1E) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SACCHARIN (UNII: FST467XS7D) POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color blue Score Shape ROUND Size Flavor BUBBLE GUM (and Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57511-0120-9 97 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2020 12/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2020 12/01/2022 Labeler - Elevate Oral Care (002863526) Registrant - Elevate Oral Care (002863526) Establishment Name Address ID/FEI Business Operations Elevate Oral Care 002863526 manufacture(57511-0120)
