Dentalclean Ultra Refreshing Extreme Ice Dental Gel

SPL v1

SPL

SPL Set ID 1496636d-6563-d474-e063-6394a90ab73d

Route

DENTAL

Published

Effective Date 2024-03-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (2.4 mg)

Inactive Ingredients

Sucralose Cetylpyridinium Chloride Anhydrous Water Hydrated Silica Sorbitol Sodium Lauryl Sulfate Menthol Carboxymethylcellulose Glycerin Sodium Benzoate Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-06-01

Description

Sodium fluoride 0.24%

Medication Information

Warnings and Precautions

WARNINGS: If more than used for brushing is accidentally swallowed, get medical help or contact poison control center right away.

Indications and Usage

Use aids in the prevention of dental cavities

Description

Sodium fluoride 0.24%

Section 50565-1

Keep out of reach of children

Section 51727-6

Water, Glycerol, Silium Dioxide, Sorbitol, Sodium Lauryl Sulphate, Carmelose Sodium, Aroma, Menthol, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose, Bright Blue (CI42090)

Section 51945-4

Section 55105-1

Anticavity

Section 55106-9

Sodium fluoride 0.24%

Section 60561-8

Store in a dry, cool place away from sunlight.

Directions

Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor

Structured Label Content

Indications and Usage (34067-9)

Use aids in the prevention of dental cavities

Warnings and Precautions (34071-1)

WARNINGS: If more than used for brushing is accidentally swallowed, get medical help or contact poison control center right away.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Water, Glycerol, Silium Dioxide, Sorbitol, Sodium Lauryl Sulphate, Carmelose Sodium, Aroma, Menthol, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose, Bright Blue (CI42090)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Sodium fluoride 0.24%

Section 60561-8 (60561-8)

Store in a dry, cool place away from sunlight.

Directions

Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Use aids in the prevention of dental cavities", "34071-1": "WARNINGS: If more than used for brushing is accidentally swallowed, get medical help or contact poison control center right away.", "50565-1": "Keep out of reach of children", "51727-6": "Water, Glycerol, Silium Dioxide, Sorbitol, Sodium Lauryl Sulphate, Carmelose Sodium, Aroma, Menthol, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose, Bright Blue (CI42090)", "55105-1": "Anticavity", "55106-9": "Sodium fluoride 0.24%", "60561-8": "Store in a dry, cool place away from sunlight.", "Directions": "Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:07.784547 · Updated: 2026-03-14T23:03:01.087200