bright smiles

SPL v1

SPL

SPL Set ID dcf7a177-c353-4d4f-aab3-c58f574be11c

Route

dental

Published

Effective Date 2017-01-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (0.1 g)

Inactive Ingredients

sorbitol water hydrated silica sodium lauryl sulfate carboxymethylcellulose sodium, unspecified form saccharin sodium methylparaben sodium propylparaben sodium

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2016-05-15

Purpose

Anticavity toothpaste

Description

Drug Facts

Medication Information

Purpose

Anticavity toothpaste

Directions

do not swallow
supervise children as necessary until capable of using without supervision
Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor.
Children under 2 years of age: Consult a dentist doctor.

Inactive Ingredients

sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharin, sodium methyl paraben, sodium propyl paraben.

Description

Drug Facts

Use

aids in the prevention of dental cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately.

Active Ingredient

Sodium Fluoride 0.22%

(0.1% w/v fluoride ion)

Principal Display Panel 42 G Tube Label

BrightSmiles

Fluoride Gel Toothpaste

NET WT. 1.5 oz (42g)

Structured Label Content

Purpose

Anticavity toothpaste

Directions

do not swallow
supervise children as necessary until capable of using without supervision
Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor.
Children under 2 years of age: Consult a dentist doctor.

Inactive Ingredients (Inactive ingredients)

sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharin, sodium methyl paraben, sodium propyl paraben.

Use

aids in the prevention of dental cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately.

Active Ingredient (Active ingredient)

Sodium Fluoride 0.22%

(0.1% w/v fluoride ion)

Principal Display Panel 42 G Tube Label (PRINCIPAL DISPLAY PANEL - 42 g Tube Label)

BrightSmiles

Fluoride Gel Toothpaste

NET WT. 1.5 oz (42g)

Advanced Ingredient Data

[{"name": "Fluoride Ion", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SORBITOL", "unii": "506T60A25R", "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": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN SODIUM", "unii": "CR6K9C2NHK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN SODIUM", "unii": "625NNB0G9N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "42229-5": "Drug Facts", "50565-1": "Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately.", "Purpose": "Anticavity toothpaste", "Directions": "do not swallow supervise children as necessary until capable of using without supervision Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor. Children under 2 years of age: Consult a dentist doctor.", "Active ingredient": "Sodium Fluoride 0.22% (0.1% w/v fluoride ion)", "Inactive ingredients": "sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharin, sodium methyl paraben, sodium propyl paraben.", "PRINCIPAL DISPLAY PANEL - 42 g Tube Label": "BrightSmiles Fluoride Gel Toothpaste NET WT. 1.5 oz (42g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:15.325598 · Updated: 2026-03-14T22:54:36.982637