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NDC 57511-0503-01 FluoriMax 5000 Sensitive 5; 1.1 g/100g; g/100g Details

FluoriMax 5000 Sensitive 5; 1.1 g/100g; g/100g

FluoriMax 5000 Sensitive is a TOPICAL PASTE, DENTIFRICE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Elevate Oral Care. The primary component is POTASSIUM NITRATE; SODIUM FLUORIDE.

Product Information

NDC	57511-0503
Product ID	57511-0503_d9f232c0-d155-536b-e053-2995a90af37d
Associated GPIs	88409902774420
GCN Sequence Number	079751
GCN Sequence Number Description	sodium fluoride/potassium nit PASTE (G) 1.1 %-5 % DENTAL
HIC3	D2A
HIC3 Description	FLUORIDE PREPARATIONS
GCN	46306
HICL Sequence Number	017889
HICL Sequence Number Description	SODIUM FLUORIDE/POTASSIUM NITRATE
Brand/Generic	Generic
Proprietary Name	FluoriMax 5000 Sensitive
Proprietary Name Suffix	n/a
Non-Proprietary Name	1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	PASTE, DENTIFRICE
Route	TOPICAL
Active Ingredient Strength	5; 1.1
Active Ingredient Units	g/100g; g/100g
Substance Name	POTASSIUM NITRATE; 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 57511-0503-01 (57511050301)

Pricing Information	N/A
NDC Package Code	57511-0503-1
Billing NDC	57511050301
Package	96 g in 1 TUBE (57511-0503-1)
Marketing Start Date	2020-08-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d9f232c0-d154-536b-e053-2995a90af37d Details

Warnings

WARNINGS: Do not swallow. Keep out of reach of children under 12 yeaars of age. Read all instructions and prescribing information before using this product. Don't freeze or expose to extreme heat.

Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

Package Label and Instructions for use

INGREDIENTS AND APPEARANCE

FLUORIMAX 5000 SENSITIVE

1.1% sodium fluoride with 5% potassium nitrate toothpaste paste, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:57511-0503
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
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SACCHARIN (UNII: FST467XS7D)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XYLITOL (UNII: VCQ006KQ1E)
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:57511-0503-2	2 in 1 BOX	06/15/2022
1	NDC:57511-0503-1	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(57511-0503)

Revised: 3/2022

Document Id: d9f232c0-d155-536b-e053-2995a90af37d

Set id: d9f232c0-d154-536b-e053-2995a90af37d

Version: 1

Effective Time: 20220311