Sodium fluoride 0.24%

Anticavity

Useaids in the prevention of dental cavities

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

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

Store in a dry, cool place away from sunlight.

Keep out of reach of children

label

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	06/01/2024

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

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

Dentalclean Ultra Refreshing Extreme Ice Dental Gel

Directions