BOTALAB HERBAL COMPLETE TOOTH- sodium fluoride paste, dentifrice

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient(s)

Sodium Fluoride 0.22% (0.10% w/w fluoride ion)

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Use(s)

■ Helps prevent cavities

WARNINGS

Warnings
■ Keep out of reach of children under 6 years of age.

■ If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

■ If irritation of the mouth or gums occurs, discontinue use and consult a dentist or physician.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age

DOSAGE & ADMINISTRATION

Directions

■ Adults and children 2 years and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

■ Children 2 to 6 years: Use only a pea-sized amount and supervise brushing to minimize swallowing.

■ Children under 2 years: Ask a dentist or physician.

OTHER SAFETY INFORMATION

Other Information

■ This product contains 1,000 ppm fluoride.

■ Store at 20°–25°C (68°–77°F).

QUESTIONS

Questions

+1-949-541-9431

riman.com

INACTIVE INGREDIENT

Inactive ingredients

Sorbitol, Water, Silica, Glycerin, Xylitol, Sodium Cocoyl Glutamate, Flavor, 2,3-Butanediol, Cellulose Gum, Lauramidopropyl Betaine, Stevia Rebaudiana Extract, Sodium Bicarbonate, Menthol, Sodium Chloride, p-Cymene, Butylene Glycol, Aloe Barbadensis Leaf Extract, Maltodextrin, Asiaticoside, Madecassic Acid, Asiatic Acid, Papain, Centella Asiatica Extract, Alcohol, Camellia Sinensis Leaf Extract, Eugenia Caryophyllus (Clove) Bud Oil, Salvia Officinalis (Sage) Extract, Daucus Carota Sativa (Carrot) Root Extract, Sodium Metabisulfite, Commiphora Myrrha Resin Extract, Potassium Sorbate, Nelumbo Nucifera Flower Extract, Prunus Mume Fruit Extract, Dextrin, Citric Acid, Lactic Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BOTALAB HERBAL COMPLETE TOOTH 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50555-201
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE GUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
SILICA (UNII: ETJ7Z6XBU4)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)
2,3-BUTANEDIOL (UNII: 45427ZB5IJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50555-201-02	1 in 1 CARTON	05/01/2026
1	NDC: 50555-201-01	150 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	05/01/2026

Labeler - KMPHARMACEUTICAL CO., LTD. (689850153)

Establishment
Name	Address	ID/FEI	Business Operations
KMPHARMACEUTICAL Co.,Ltd.		689850153	manufacture(50555-201)