Fluorimax 5000 1.1% Sodium Fluoride & 5% Potassium Nitrate Toothpaste Spearmint

SPL v2

SPL

SPL Set ID d9f232c0-d154-536b-e053-2995a90af37d

Route

TOPICAL

Published

Effective Date 2022-06-15

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (1.1 g) Nitrate Ion (5 g)

Inactive Ingredients

Saccharin Glycerin Hydrated Silica Xylitol Potassium Phosphate, Monobasic Water Sorbitol

Identifiers & Packaging

Pill Appearance

Shape: round Color: white

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2022-06-15

Medication Information

Warnings

Directions

Package Label and Instructions for Use

Structured Label Content

Warnings

Directions

Package Label and Instructions for Use (Package Label and Instructions for use)

Advanced Ingredient Data

[{"name": "SACCHARIN", "unii": "FST467XS7D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "1.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM PHOSPHATE, MONOBASIC", "unii": "4J9FJ0HL51", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NITRATE ION", "unii": "T93E9Y2844", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:49:41.332321 · Updated: 2026-03-14T22:34:06.521153