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

Purpose

Anticavity

Description

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

Medication Information

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.

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.

Description

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

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

Use

aids in the prevention of dental cavities.

Active Ingredient

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

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

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

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.

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.

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

Use

aids in the prevention of dental cavities.

Active Ingredient (Active ingredient)

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

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

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