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SPL v7

SPL

SPL Set ID f47cb584-eb8a-4297-ba32-5f435e85aacb

Route

ORAL

Published

Effective Date 2018-12-15

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (1.1 g)

Inactive Ingredients

Water Sorbitol Hydrated Silica Polyethylene Glycol 8000 Carboxymethylcellulose Xylitol Sodium Phosphate, Monobasic, Monohydrate Titanium Dioxide Saccharin Sodium Tribasic Calcium Phosphate

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2011-08-01

Description

DRUG FACTS ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

Indications and Usage

NeutraMaxxtm 5000 with Tri-Calcium Phosphate is a self applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity

Purpose

For prevention of tooth decay, orthodontic decalcification and hypersensitivity.

Medication Information

Indications and Usage

NeutraMaxxtm 5000 with Tri-Calcium Phosphate is a self applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity

Purpose

For prevention of tooth decay, orthodontic decalcification and hypersensitivity.

Description

DRUG FACTS ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

Package Label

REFRESHING MINT FLAVOR RELIEVES SENSITIVITY

ANTI-CAVITY TOOTHPASTE NeutraMaxx tm 5000 TCP XYLITO1.1% Neutral Sodium Fluoride 5000 ppm Sweetened with Xylitol

DOES NOT CONTAIN SODIUM LAURYL SULFATE RX ONLY Net wt. 4 oz (112 G)

Manufactured By: MASSCO DENTAL A Division of Dunagin Pharmaceuticals, Gravette, AR (479) 787-5168 www.masscodental.net

res

Purpose Section

For prevention of tooth decay, orthodontic decalcification and hypersensitivity.

Warning Section

Warnings Do not swallow For topical use only

Active Ingredient Section

DRUG FACTS ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

Inactive Ingredient Section

Inactive Ingredients: Deionized Water, Sorbitol, Hydrated Silica, PEG, Carboxymethylcellulose, Xylitol, MonoSodium Phosphate, Titanium Dioxide, Mint Flavor, Sodium Saccharin, Tri-Calcium Phosphate

Questions? Comments? Section

Call 1-479-787-5168 M-F 9am to 5 pm CST

Indications and Usage Section

NeutraMaxxtm 5000 with Tri-Calcium Phosphate is a self applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity

Directions: Use As Directed Section

This prescription dentifrice is recommended for adults and pediatric patients 6 years and older

Apply a thin ribbon of NeutraMaxxtm 5000 TCP along the length of the toothbrush no more than "pea size" total dose. Brush for two minutes.

After brushing ADULTS - Expectorate, do not eat for 30 minutes. CHILDREN 6 YEARS OF AGE OR OLDER - Expectorate and rinse mouth with water. Use at bedtime in place of your regular toothpaste or as directed by your dental professional.

Keep Out of Reach of Children Section

As with all medications, keep out of reach of children.

Structured Label Content

Package Label

REFRESHING MINT FLAVOR RELIEVES SENSITIVITY

ANTI-CAVITY TOOTHPASTE NeutraMaxx tm 5000 TCP XYLITO1.1% Neutral Sodium Fluoride 5000 ppm Sweetened with Xylitol

DOES NOT CONTAIN SODIUM LAURYL SULFATE RX ONLY Net wt. 4 oz (112 G)

Manufactured By: MASSCO DENTAL A Division of Dunagin Pharmaceuticals, Gravette, AR (479) 787-5168 www.masscodental.net

res

Purpose Section

For prevention of tooth decay, orthodontic decalcification and hypersensitivity.

Warning Section

Warnings Do not swallow For topical use only

Active Ingredient Section

DRUG FACTS ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

Inactive Ingredient Section

Inactive Ingredients: Deionized Water, Sorbitol, Hydrated Silica, PEG, Carboxymethylcellulose, Xylitol, MonoSodium Phosphate, Titanium Dioxide, Mint Flavor, Sodium Saccharin, Tri-Calcium Phosphate

Questions? Comments? Section

Call 1-479-787-5168 M-F 9am to 5 pm CST

Indications and Usage Section

NeutraMaxxtm 5000 with Tri-Calcium Phosphate is a self applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity

Directions: Use As Directed Section

This prescription dentifrice is recommended for adults and pediatric patients 6 years and older

Apply a thin ribbon of NeutraMaxxtm 5000 TCP along the length of the toothbrush no more than "pea size" total dose. Brush for two minutes.

Keep Out of Reach of Children Section

As with all medications, keep out of reach of children.

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "1.1", "strengthDenominator": "112", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 8000", "unii": "Q662QK8M3B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE", "unii": "05JZI7B19X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE", "unii": "593YOG76RN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIBASIC CALCIUM PHOSPHATE", "unii": "91D9GV0Z28", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Package Label": "REFRESHING MINT FLAVOR RELIEVES SENSITIVITY ANTI-CAVITY TOOTHPASTE NeutraMaxx tm 5000 TCP XYLITO1.1% Neutral Sodium Fluoride 5000 ppm Sweetened with Xylitol DOES NOT CONTAIN SODIUM LAURYL SULFATE RX ONLY Net wt. 4 oz (112 G) Manufactured By: MASSCO DENTAL A Division of Dunagin Pharmaceuticals, Gravette, AR (479) 787-5168 www.masscodental.net res", "Purpose Section": "For prevention of tooth decay, orthodontic decalcification and hypersensitivity.", "Warning Section": "Warnings Do not swallow For topical use only ", "Active Ingredient Section": "DRUG FACTS ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE", "Inactive Ingredient Section": "Inactive Ingredients: Deionized Water, Sorbitol, Hydrated Silica, PEG, Carboxymethylcellulose, Xylitol, MonoSodium Phosphate, Titanium Dioxide, Mint Flavor, Sodium Saccharin, Tri-Calcium Phosphate", "Questions? Comments? Section": "Call 1-479-787-5168 M-F 9am to 5 pm CST", "Indications and Usage Section": "NeutraMaxxtm 5000 with Tri-Calcium Phosphate is a self applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity", "Directions: Use As Directed Section": "This prescription dentifrice is recommended for adults and pediatric patients 6 years and older Apply a thin ribbon of NeutraMaxxtm 5000 TCP along the length of the toothbrush no more than "pea size" total dose. Brush for two minutes. After brushing ADULTS - Expectorate, do not eat for 30 minutes. CHILDREN 6 YEARS OF AGE OR OLDER - Expectorate and rinse mouth with water. Use at bedtime in place of your regular toothpaste or as directed by your dental professional.", "Keep Out of Reach of Children Section": "As with all medications, keep out of reach of children."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:39:37.092759 · Updated: 2026-03-14T21:58:32.238924