71035-903 Charcoal Mint Dentistry

SPL v2

SPL

SPL Set ID 72733342-a3ac-0548-e053-2991aa0a2a75

Route

DENTAL

Published

Effective Date 2016-09-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.24 g)

Inactive Ingredients

Sorbitol Hydrated Silica Hydroxyethyl Cellulose (40 Mpa.s At 2%) Water Carboxymethylcellulose Glycerin Sodium Phosphate, Tribasic, Anhydrous Sodium Benzoate Sodium Lauryl Sulfate Saccharin

Identifiers & Packaging

Pill Appearance

Color: black

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2016-09-04

Description

Sodium Fluoride 0.24%

Purpose

anticavity

Medication Information

Purpose

anticavity

Description

Sodium Fluoride 0.24%

Uses

aids in the prevention of dental vavities.

Section 50565-1

Keep out of reach of children.

Section 51945-4

Warnings

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 right away.

Directions

Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or doctor.

Instruct Children under 6 years of age in good burshing and rinsing ahnbits(to mininize swallowing ).supervise children as necessary until catlble of using without supervision.

Children under 2 years:Consult a dentist or doctor.

Active Ingredients

Sodium Fluoride 0.24%

Inactive Ingredient

HYDRATED SILICA,HYDROXYETHYL CELLULOSE,WATER,CARBOXYMETHYLCELLULOSE,SACCHARIN SODIUM,SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS.SODIUM BENZOATE,SODIUM LAURYL SULFATE,SORBITOL,GLYCERIN

Structured Label Content

Uses

aids in the prevention of dental vavities.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose

anticavity

Warnings

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 right away.

Directions

Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or doctor.

Instruct Children under 6 years of age in good burshing and rinsing ahnbits(to mininize swallowing ).supervise children as necessary until catlble of using without supervision.

Children under 2 years:Consult a dentist or doctor.

Active Ingredients (Active ingredients)

Sodium Fluoride 0.24%

Inactive Ingredient (INACTIVE INGREDIENT)

HYDRATED SILICA,HYDROXYETHYL CELLULOSE,WATER,CARBOXYMETHYLCELLULOSE,SACCHARIN SODIUM,SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS.SODIUM BENZOATE,SODIUM LAURYL SULFATE,SORBITOL,GLYCERIN

Advanced Ingredient Data

[{"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL CELLULOSE (40 MPA.S AT 2%)", "unii": "I2N4ZF9233", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE", "unii": "05JZI7B19X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.24", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS", "unii": "SX01TZO3QZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN", "unii": "FST467XS7D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "aids in the prevention of dental vavities.", "50565-1": "Keep out of reach of children.", "Purpose": "anticavity", "Warnings": "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 right away.", "Directions": "Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or doctor. Instruct Children under 6 years of age in good burshing and rinsing ahnbits(to mininize swallowing ).supervise children as necessary until catlble of using without supervision. Children under 2 years:Consult a dentist or doctor.", "Active ingredients": "Sodium Fluoride 0.24%", "INACTIVE INGREDIENT": "HYDRATED SILICA,HYDROXYETHYL CELLULOSE,WATER,CARBOXYMETHYLCELLULOSE,SACCHARIN SODIUM,SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS.SODIUM BENZOATE,SODIUM LAURYL SULFATE,SORBITOL,GLYCERIN"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:37.781081 · Updated: 2026-03-14T22:55:14.803903