DENTALCLEAN ULTRA REFRESHING EXTREME ICE DENTAL GEL- sodium fluoride 0.24% paste, dentifrice

Dentalclean Ultra Refreshing Extreme Ice Dental Gel by

Drug Labeling and Warnings

Dentalclean Ultra Refreshing Extreme Ice Dental Gel by is a Otc medication manufactured, distributed, or labeled by Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium fluoride 0.24%

PURPOSE

Anticavity

INDICATIONS & USAGE

Useaids in the prevention of dental cavities

WARNINGS

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

Directions

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

INACTIVE INGREDIENT

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

OTHER SAFETY INFORMATION

Store in a dry, cool place away from sunlight.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DENTALCLEAN ULTRA REFRESHING EXTREME ICE DENTAL GEL 
sodium fluoride 0.24% paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84035-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MENTHOL (UNII: L7T10EIP3A)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84035-001-01	1 in 1 CARTON	06/01/2024
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	06/01/2024

Labeler - Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda (901719567)

Establishment
Name	Address	ID/FEI	Business Operations
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda		901719567	manufacture(84035-001)