botalab HERBAL COMPLETE TOOTHPASTE

Manufacturer
KMPHARMACEUTICAL CO., LTD. | KMPHARMACEUTICAL Co.,Ltd.
Effective date
2026-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:56:17

Label at a glance#

Productbotalab HERBAL COMPLETE TOOTH
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient(s)

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

OTC - PURPOSE SECTION

Purpose

Anticavity

INDICATIONS & USAGE SECTION

Use(s)

■ Helps prevent cavities

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age

DOSAGE & ADMINISTRATION SECTION

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).

OTC - QUESTIONS SECTION

Questions

+1-949-541-9431

riman.com

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ImageCarton Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN1
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD1
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138800256370696GTIN-13: 8800256370696
EAN-13: 8800256370696
GTIN storage (14 digits): 08800256370696
herbal toothpaste carton.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50555-201-01botalab HERBAL COMPLETE TOOTH150 g in 1 TUBEPASTE, DENTIFRICE1501
50555-201-02botalab HERBAL COMPLETE TOOTH1 in 1 CARTONPASTE, DENTIFRICE11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50555-20150555-201-01, 50555-201-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
botalab HERBAL COMPLETE TOOTHSODIUM FLUORIDEKMPHARMACEUTICAL CO., LTD.51365ef7-ed94-2650-e063-6394a90ab89e2026-05-07WarningsExact identifier
ndc (package): 50555-201-01
ndc (package): 50555-201-02
ndc (product): 50555-201
ndc11 (package): 50555020101
ndc11 (package): 50555020102
spl id: 51365ef7-ed95-2650-e063-6394a90ab89e
spl set id: 51365ef7-ed94-2650-e063-6394a90ab89e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.