DENTALCLEAN ADVANCE PRO- sodium fluoride 0.24% paste, dentifrice

Dentalclean Advance Pro by

Drug Labeling and Warnings

Dentalclean Advance Pro 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

Use Aids in the prevention of cavities Helps prevent gingivitis Helps interfere with harmful effects of plaque associated with

gingivitis Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

WARNINGS

WARNINGS:

When using this product for sensitivity , do not use longer than 4 weeks unless recommended by a dentist.
Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen
gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Directions

Adults and children 12 years of age and older: apply at least a 1 inch strip of the product onto a soft bristled toothbrush.

Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist.

Make sure to brush all sensitive areas of the teeth.
Do not swallow.
Children under 12 year of age: consult a dentist.

Inactive Ingredients

Water, Silicon Dioxide, Glycerol, Sorbitol, Sodium Lauryl Sulphate, Potassium Citrate Monohydrate, Aroma, Carmellose Sodium, Titanium Dioxide, Tetrasodium Pyrophosphate, Menthol, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose, Methyl Salicylate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DENTALCLEAN ADVANCE PRO 
sodium fluoride 0.24% paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84035-013
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
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)
METHYL SALICYLATE (UNII: LAV5U5022Y)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84035-013-06	1 in 1 CARTON	03/01/2026
1		181 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	03/01/2026

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(84035-013)