Fluorimax 5000 1.1% Sodium Fluoride Toothpaste

SPL v1

SPL

SPL Set ID ae45ae2d-a21f-0a05-e053-2995a90a4d5e

Route

TOPICAL

Published

Effective Date 2020-09-01

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (1.1 g)

Identifiers & Packaging

Pill Appearance

Shape: round Color: white

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2020-09-01

Description

Do not swallow. Keep out of reach of children under 6 years of age. Read instructions and prescribing information before using product.

Medication Information

Description

Do not swallow. Keep out of reach of children under 6 years of age. Read instructions and prescribing information before using product.

Warnings

Do not swallow. Keep out of reach of children under 6 years of age. Read instructions and prescribing information before using product.

Label and Instruction for Use

Structured Label Content

Warnings

Do not swallow. Keep out of reach of children under 6 years of age. Read instructions and prescribing information before using product.

Label and Instruction for Use (Label and instruction for use)

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "1.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Warnings": "Do not swallow. Keep out of reach of children under 6 years of age. Read instructions and prescribing information before using product."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:35:30.397756 · Updated: 2026-03-14T21:43:34.600459