DENTALCLEAN WHITENING MAX- sodium fluoride 0.24% paste, dentifrice 
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda

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Dentalclean Whitening Max

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

• Children 2 to 6 years of age: instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without supervision.

• Children under 2 years of age: do not use unless directed by a dentist or doctor or as directed by a dentist or doctor.

Store in a dry, cool place away from sunlight.

Inactive Ingredients

Glycerin, Silium Dioxide, Water, Sodium Lauryl Sulphate, Monohydrate Potassium Citrate, Sorbitol, Aroma, Carmetlose Sodium, Tetrasodium Pyrophosphate, Menthol, Cetytpyridinium Chloride, Sodium Benzoate, Titanium Dioxide, Sucralose, D-Limonene.

Keep out of reach of children under 6 years of age

Packlabel

DENTALCLEAN WHITENING MAX 
sodium fluoride 0.24% paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84035-004
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MENTHOL (UNII: L7T10EIP3A)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITOL (UNII: 506T60A25R)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84035-004-031 in 1 CARTON06/01/2024
1104 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02106/01/2024
Labeler - Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda (901719567)
Establishment
NameAddressID/FEIBusiness Operations
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda901719567manufacture(84035-004)

Revised: 5/2024
Document Id: 17e234b1-5dc0-ef03-e063-6294a90ae82c
Set id: 17e2364e-2511-3021-e063-6294a90a40e1
Version: 1
Effective Time: 20240507
 
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda