ROROBELL WAWA TOOTH- sodium monofluorophosphate paste, dentifrice

Rorobell WaWa Tooth by

Drug Labeling and Warnings

Rorobell WaWa Tooth by is a Otc medication manufactured, distributed, or labeled by ROROBELL, DONG IL PHARMS CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Monofluorophosphate 0.72%

INACTIVE INGREDIENTS

Calcium Carbonate, Dicalcium Phosphate Dihydrate, Aluminium Chlorohydrate, Sorbitol, Water, Glycerin, Sodium Cocoyl Glutamate, Cellulose Gum, Thymus quinquecostatus Flavor, Menthol, Xylitol, Erythritol, Mentha Piperita (Peppermint) Oil, Hydroxyapatite, Sodium Copper Chlorophyllin, Allyl Isothiocyanate, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Aloe Barbadensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Citrus Grandis (Grapefruit) Fruit Extract, Taraxacum Officinale (Dandelion) Rhizome, Pistacia Lentiscus (Mastic) Gum

PURPOSE

Caries prevention

WARNINGS

■ Contains 950ppm of fluoride.
■ Do not swallow and rinse mouth thoroughly after use
■ If you experience any problems with your gums or mouth during use,
discontinue use and consult your doctor.
■ For children under 6 years of age, use small amounts of toothpaste. And use it
under the supervision of a guardian to avoid sucking or swallowing.
■ Consult a physician or dentist immediately if a child under 6 years old has
swallowed large quantities.
■ Keep out of the reach of children under 6 years of age.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children under 6 years of age.

Uses

■ Keep your teeth white and strong.
■ Keep your mouth clean.
■ Refresh the inside of the mouth.
■ Prevents tooth decay caused by fluoride and removes bad breath.
■ Increases aesthetic effect.
■ Prevention of gingivitis and periodontitis (alveolar fistula)
■ Prevention of periodontal disease
■ Prevention of gum disease
■ Prevention of plaque deposition, removal of plaque (anti-prag)

Directions

■ Brushing the teeth with a suitable amount

Other Information

Airtight container, Store in normal temperature (1~30℃)

QUESTIONS

02-515-0529
www.rorobell.com

PACKAGE LABEL (Tube)NDC:

81275-010-01

PACKAGE LABEL (Carton)NDC:

81275-010-02

INGREDIENTS AND APPEARANCE

ROROBELL WAWA TOOTH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81275-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.72 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Calcium Carbonate (UNII: H0G9379FGK)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81275-010-02	1 in 1 CARTON	12/01/2020
1	NDC: 81275-010-01	100 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 final	part355	12/01/2020

Labeler - ROROBELL (695157824)

Registrant - ROROBELL (695157824)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(81275-010)