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NDC 57511-0504-01 FluoriMax 5000 1.1 g/100g Details

FluoriMax 5000 1.1 g/100g

FluoriMax 5000 is a TOPICAL PASTE, DENTIFRICE in the HUMAN PRESCRIPTION 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: 57511-0504-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	57511-0504
Product ID	57511-0504_d9e462d9-f0fe-4168-e053-2995a90a95b2
Associated GPIs	88402020004418
GCN Sequence Number	060385
GCN Sequence Number Description	fluoride (sodium) PASTE (G) 1.1 % DENTAL
HIC3	D2A
HIC3 Description	FLUORIDE PREPARATIONS
GCN	26528
HICL Sequence Number	001127
HICL Sequence Number Description	FLUORIDE (SODIUM)
Brand/Generic	Generic
Proprietary Name	FluoriMax 5000
Proprietary Name Suffix	n/a
Non-Proprietary Name	1.1% Sodium Fluoride Toothpaste
Product Type	HUMAN PRESCRIPTION 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	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 57511-0504-01 (57511050401)

Pricing Information	N/A
NDC Package Code	57511-0504-1
Billing NDC	57511050401
Package	96 g in 1 TUBE (57511-0504-1)
Marketing Start Date	2020-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d9e462d9-f0fd-4168-e053-2995a90a95b2 Details

Warnings

WARNINGS: Do not swallow. Keep out of reach of children under 6 years of age. Read all instructions and prescribing information before using this product. Do not freeze or expose to extreme heat.

Package Label and Instructions for use

INGREDIENTS AND APPEARANCE

FLUORIMAX 5000

1.1% sodium fluoride toothpaste paste, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:57511-0504
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
SACCHARIN (UNII: FST467XS7D)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

Product Characteristics
Color	white	Score
Shape	ROUND	Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:57511-0504-2	2 in 1 BOX	06/15/2022
1	NDC:57511-0504-1	96 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/15/2022

Labeler - Elevate Oral Care (002863526)

Registrant - Elevate Oral Care (002863526)

Name	Address	ID/FEI	Business Operations
Establishment
Elevate Oral Care		002863526	manufacture(57511-0504)

Revised: 3/2022

Document Id: d9e462d9-f0fe-4168-e053-2995a90a95b2

Set id: d9e462d9-f0fd-4168-e053-2995a90a95b2

Version: 1

Effective Time: 20220310