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NDC 57511-0122-08 Just Right 5000 1.1 g/100g Details
Just Right 5000 1.1 g/100g
Just Right 5000 is a TOPICAL GEL, DENTIFRICE in the HUMAN OTC DRUG category. It is labeled and distributed by Elevate Oral Care. The primary component is SODIUM FLUORIDE.
MedlinePlus Drug Summary
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 57511-0122-08Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride
Product Information
| NDC | 57511-0122 |
|---|---|
| Product ID | 57511-0122_cfcf5811-ad65-6853-e053-2a95a90a5532 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Just Right 5000 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | 1.1% Sodium Fluoride Toothpaste |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL, DENTIFRICE |
| Route | TOPICAL |
| Active Ingredient Strength | 1.1 |
| Active Ingredient Units | g/100g |
| Substance Name | SODIUM FLUORIDE |
| Labeler Name | Elevate Oral Care |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | n/a |
Package
Package Images
NDC 57511-0122-08 (57511012208)
| NDC Package Code | 57511-0122-8 |
|---|---|
| Billing NDC | 57511012208 |
| Package | 97 g in 1 TUBE (57511-0122-8) |
| Marketing Start Date | 2020-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9005f0c8-53e4-2120-e053-2995a90a8823 Details
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, Xylitol, Glycerin, Hydrated silica, PEG-8, Caramel Apple Flavor, Sodium Lauryl Sulfate, Xanthan Gum, Potassium Phosphate, Sodium Benzoate, Sodium Saccharin, Mica, FD&C Red 40
Questions? 1-877-866-9113 or visit our website at www.elevateoralcare.com
Helps protect against Cavities
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.
INGREDIENTS AND APPEARANCE
| JUST RIGHT 5000
1.1% sodium fluoride toothpaste gel, dentifrice |
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| Labeler - Elevate Oral Care (002863526) |
| Registrant - Elevate Oral Care (002863526) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Elevate Oral Care | 002863526 | repack(57511-0122) | |