Label: JUST RIGHT 5000- 1.1% sodium fluoride toothpaste gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 57511-0120-8 - Packager: Elevate Oral Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 7, 2018
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 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:57511-0120-8 91 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/2018 Labeler - Elevate Oral Care (002863526) Registrant - Elevate Oral Care (002863526) Establishment Name Address ID/FEI Business Operations Elevate Oral Care 002863526 manufacture(57511-0120)
