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NDC 57511-0101-03 FluoriMax 5000 1.1 g/100g Details
FluoriMax 5000 1.1 g/100g
FluoriMax 5000 is a TOPICAL PASTE, 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: 57511-0101-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride
Product Information
| NDC | 57511-0101 |
|---|---|
| Product ID | 57511-0101_ce424ed3-a1ee-5d16-e053-2a95a90a34ff |
| 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 | FluoriMax 5000 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | 1.1% Sodium Fluoride Toothpaste |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PASTE, 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 | OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 57511-0101-03 (57511010103)
| NDC Package Code | 57511-0101-3 |
|---|---|
| Billing NDC | 57511010103 |
| Package | 96 g in 1 TUBE (57511-0101-3) |
| Marketing Start Date | 2015-02-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 81c2c9f2-1a2e-474e-b150-4e336f213699 Details
OTC - ACTIVE INGREDIENT SECTION
Sodium Fluoride 1.1% Anticavity
INDICATIONS & USAGE SECTION
A dental caries preventive for once daily self appied topical use. It is well established that 1.1% sodium fluoride is safe and effective as a caries preventive when applied frequently with mouthpiece applicators. Use once daily in place of your regular toothpaste unless otherwise instructed by your dental professional.
WARNINGS SECTION
Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if water fluoridation exceeds 0.7 ppm, since younger patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 requires special supervision to preven repeated swallowing of dental cream which could cause dental fluorosis. Read instructions carefully before using. Keep out of reach of infants and children.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of infants and children.
INSTRUCTIONS FOR USE SECTION
Directions: *adults and children 2 years and older: wet a toothbrush and pump once to apply a pea-sized (~0.35 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, deionized water, hydrated silica, xylitol, glycerin, PEG 400, sodium lauryl sulfate, potassium phosphate monobasic, titanium dioxide, vanilla mint flavor, sodium saccharin
Questions? 1-877-866-9113 or visit our website at www.elevateoralcare.com
Helps protect against Cavities
Directions: adults and pediatric patients 6 and older, apply a thin ribbon of FluoriMax toothpaste to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bed time. After use, adults spit, do not eat, drink or rinse for 30 minutes. Pediatric patients 6-16 spit after use and rinse mouth thoroughly.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| FLUORIMAX 5000
1.1% sodium fluoride toothpaste paste, 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 | manufacture(57511-0101) | |