73297-001 Charcoal Mint Dentistry

SPL v1

SPL

SPL Set ID 912a6ca0-43c8-4d9e-e053-2a95a90ac03b

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 Polyethylene Glycol 1000 Water Carboxymethylcellulose Xanthan Gum Sodium Pyrophosphate Sodium Benzoate Sodium Lauryl Sulfate Saccharin Menthol

Identifiers & Packaging

Pill Appearance

Color: black

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2019-08-28

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

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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

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Source: dailymed · Ingested: 2026-02-15T11:56:51.057991 · Updated: 2026-03-14T22:55:36.629297