Drug Facts

Drug Facts

SPL v9

SPL

SPL Set ID a47a6502-efb2-4072-9562-cbe293531c2b

Route

ORAL

Published

Effective Date 2022-08-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Fluoride Ion (1.4 mg)

Inactive Ingredients

Sorbitol Glycerin Calcium Pyrophosphate Water Hydrated Silica Xylitol Silicon Dioxide Hydroxyethyl Cellulose, Unspecified Isoceteth-20 Xanthan Gum Sodium Benzoate Calcium Lactate Anhydrous

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-09-01

Description

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Use

aids in the prevention of dental cavities.

Directions

•
adults and children 2 years of age and older:
- o
  apply toothpaste onto a toothbrush
- o
  brush teeth thoroughly, preferable after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimizing swallowing. Spit out after brushing.
- o
  to minimize swallowing for children under 6 years of age, use a pea-sized amoun and supervise brushing and rinsing until good habits are established.
•
children under 2 years of age: Consult a dentist or doctor.

Active Ingredient

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Other Information

store at or below 25ºC (77ºF)

Inactive Ingredients

sorbitol, glycerin, calcium pyrophosphate, water, hydrated silica, xylitol, silica, hydroxyethyl cellulose, isoceteth-20, cellulose gum, flavor, sodium benzoate, sodium lactate.

Additional Information

This product contains no Sodium Lauryl Sulfate (SLS)

Trademarks are owned by or licensed to the GSK group of companies.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

@2019 GSK group of companies or its licensor.

Questions or Comments?

1-800-922-5856

Questions Or Comments?

Call toll-free 1-800-922-5856

Principal Display Panel

NDC 0135-0577-01

biotene ^®

Fluoride Toothpaste

SPECIALLY FORMULATED TO NOT IRRITATE

Helps prevent cavities & strengthen teeth

Gentle Formula

GENTLE MINT

NET WT 4.3 OZ (121.9g)

1000114 Front Carton

When Using This Product,

if irritation occurs discontinue use.

Keep Out of Reach of Children Under 6 Years of Age.

If more than used for bushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Use

aids in the prevention of dental cavities.

Purpose

Anticavity

Directions

•
adults and children 2 years of age and older:
- o
  apply toothpaste onto a toothbrush
- o
  brush teeth thoroughly, preferable after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimizing swallowing. Spit out after brushing.
- o
  to minimize swallowing for children under 6 years of age, use a pea-sized amoun and supervise brushing and rinsing until good habits are established.
•
children under 2 years of age: Consult a dentist or doctor.

Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Other Information (Other information)

store at or below 25ºC (77ºF)

Inactive Ingredients (Inactive ingredients)

sorbitol, glycerin, calcium pyrophosphate, water, hydrated silica, xylitol, silica, hydroxyethyl cellulose, isoceteth-20, cellulose gum, flavor, sodium benzoate, sodium lactate.

Additional Information (Additional information)

This product contains no Sodium Lauryl Sulfate (SLS)

Trademarks are owned by or licensed to the GSK group of companies.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

@2019 GSK group of companies or its licensor.

Questions or Comments?

1-800-922-5856

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-922-5856

Principal Display Panel

NDC 0135-0577-01

biotene ^®

Fluoride Toothpaste

SPECIALLY FORMULATED TO NOT IRRITATE

Helps prevent cavities & strengthen teeth

Gentle Formula

GENTLE MINT

NET WT 4.3 OZ (121.9g)

1000114 Front Carton

When Using This Product, (When using this product,)

if irritation occurs discontinue use.

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If more than used for bushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "1.4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM PYROPHOSPHATE", "unii": "X69NU20D19", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "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": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL CELLULOSE, UNSPECIFIED", "unii": "T4V6TWG28D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOCETETH-20", "unii": "O020065R7Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM LACTATE ANHYDROUS", "unii": "2URQ2N32W3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities.", "Purpose": "Anticavity", "Directions": "• adults and children 2 years of age and older: o apply toothpaste onto a toothbrush o brush teeth thoroughly, preferable after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimizing swallowing. Spit out after brushing. o to minimize swallowing for children under 6 years of age, use a pea-sized amoun and supervise brushing and rinsing until good habits are established. • children under 2 years of age: Consult a dentist or doctor.", "Active ingredient": "Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)", "Other information": "store at or below 25ºC (77ºF)", "Inactive ingredients": "sorbitol, glycerin, calcium pyrophosphate, water, hydrated silica, xylitol, silica, hydroxyethyl cellulose, isoceteth-20, cellulose gum, flavor, sodium benzoate, sodium lactate.", "Additional information": "This product contains no Sodium Lauryl Sulfate (SLS) Trademarks are owned by or licensed to the GSK group of companies. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 @2019 GSK group of companies or its licensor. Questions or Comments? 1-800-922-5856", "Questions or comments?": "Call toll-free 1-800-922-5856", "Principal Display Panel": "NDC 0135-0577-01 biotene ® Fluoride Toothpaste SPECIALLY FORMULATED TO NOT IRRITATE Helps prevent cavities & strengthen teeth Gentle Formula GENTLE MINT NET WT 4.3 OZ (121.9g) 1000114 Front Carton", "When using this product,": "if irritation occurs discontinue use.", "Keep out of reach of children under 6 years of age.": "If more than used for bushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:15.061263 · Updated: 2026-03-14T23:04:50.432090