DENTALCLEAN BLUE DIAMOND ALCOHOL FREE MOUTHWASH- sodium fluoride 0.05% rinse 
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda

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Dentalclean Blue Diamond Alcohol Free Mouthwash

Sodium fluoride 0.05%

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

Adults and children of 6 years of age and older:

• Use once a day after brushing your teeth with a toothpaste.
•Remove cap
• Hold bottle upright and squeeze
•Pour out
•Vigorously swish between your teeth for 1 minute and then spit out
• Do not swallow the rinse.
• Do not eat or drink for 30 minutes after rinsing.

Store in a dry, cool place away from sunlight.

Inactive Ingredients

Water, Glycerol, Ethoxylated Hydrogenated Rice Oil, Sorbitol, Aroma, Sodium Edetate, Sodium Benzoate, Cetylpyridinium Chloride, Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Sucralose, Brilliant Blue (CI 42090)

Keep out of reach of children under 6 years of age

Packlabel

DENTALCLEAN BLUE DIAMOND ALCOHOL FREE MOUTHWASH 
sodium fluoride 0.05% rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84035-009
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)  
TETRASODIUM EDETATE DIHYDRATE (UNII: 3JGX4KKZ4A)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SORBITOL (UNII: 506T60A25R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
GLYCEROL FORMAL (UNII: 3L7GR2604E)  
POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84035-009-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2024
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(84035-009)

Revised: 5/2024
Document Id: 188167b2-4e8c-febc-e063-6294a90af681
Set id: 1881658c-e371-5513-e063-6394a90a465f
Version: 1
Effective Time: 20240515
 
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda