Need For You Limpio Tooth

Manufacturer
NEED FOR YOU | DONG IL PHARMS CO., LTD
Effective date
2020-12-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:58:23

Label at a glance#

ProductNeed For You Limpio Tooth
Active ingredientSodium Monofluorophosphate
Label structure10 sections

Indications and 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)

Dosage and administration

■ Brushing the teeth with a suitable amount

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Sodium Cocoyl Glutamate, Cellulose Gum, Glycerin, Menthol, Mentha Piperita (Peppermint) Oil, Mentha Spicata Herb Oil, Herb Flavor, Stevioside, Hydroxyapatite, Xylitol, Citrus Grandis (Grapefruit) Seed Extract, Propolis Wax, Chamomilla Recutita (Matricaria) Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Eucalyptus Globulus Leaf Extract, Aloe Barbadensis Leaf Extract, Taraxacum Officinale (Dandelion) Rhizome, Ascorbic Acid

PURPOSE

OTC - PURPOSE SECTION

Caries prevention

WARNINGS

WARNINGS SECTION

■ Contains 1000ppm 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

■ 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

DOSAGE & ADMINISTRATION SECTION

■ Brushing the teeth with a suitable amount

Other Information

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81373-010-022024-12-26C16284748780-1f386c64a-407d-0266-e053-dadaa90a7c1a181d12b0-a1bf-4c5e-b7d1-7e0e8db95153
81373-010-022023-01-30C16284748780-1f386c64a-407d-0266-e053-dadaa90a7c1a181d12b0-a1bf-4c5e-b7d1-7e0e8db95153

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81373-01081373-010-01, 81373-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
2a3752d8-32a0-0f58-e063-6394a90a0e83181d12b0-a1bf-4c5e-b7d1-7e0e8db951532024-12-26WarningsExact identifier
spl set id: 181d12b0-a1bf-4c5e-b7d1-7e0e8db95153

Reported adverse events (FAERS/openFDA)#

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