DENTALCLEAN BLUE DIAMOND ALCOHOL FREE MOUTHWASH- sodium fluoride 0.05% rinse

Dentalclean Blue Diamond Alcohol Free Mouthwash by

Drug Labeling and Warnings

Dentalclean Blue Diamond Alcohol Free Mouthwash 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 0.05%

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

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.

OTHER SAFETY INFORMATION

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

Keep out of reach of children under 6 years of age

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DENTALCLEAN BLUE DIAMOND ALCOHOL FREE MOUTHWASH 
sodium fluoride 0.05% rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84035-009
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84035-009-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2024

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(84035-009)