FDA.reportPublic FDA data

OPRECARE 3SET (07,12,21)

Manufacturer
O'PRECARE | Kolmar Korea Co., Ltd.
Effective date
2017-10-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:52:41

Label at a glance#

ProductOPRECARE 3SET (07,12,21)
Active ingredientSODIUM MONOFLUOROPHOSPHATE, SILICON DIOXIDE
Label structure8 sections

Indications and uses

Helps protect against cavities, plaque, gingivitis

Dosage and administration

Directions   Adults and children 2 years of age 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 childs brushing and rinsing (to minimize swallowing)  Children under 2 years  Ask a dentist or physician

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredients 
 O'PRECARE 07   Sodium Monofluorophosphate (0.6%)
 O'PRECARE 12    Silica (Silicon dioxide) (2.85%)
 O'PRECARE 21 Sodium Monofluorophosphate (0.6%)

Purpose

OTC - PURPOSE SECTION

Anticavity

Warnings

WARNINGS SECTION

When using this product, if irritation occurs stop use and ask a dentist. Do not swallow, and rinse enough after use. Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

Helps protect against cavities, plaque, gingivitis

Directions

DOSAGE & ADMINISTRATION SECTION

Directions 
 Adults and children 2 years of age 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 childs brushing and rinsing (to minimize swallowing)
 Children under 2 years Ask a dentist or physician

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center right away.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients 
 O'PRECARE 07                                                 Silica, Tocopheryl Acetate, Piridokssin Hydrochloride, Sodium Pyrophosphate, Sorbitol, PEG-32, Hydrated Silica, Cellulose Gum, Titanium Oxide, Xylitol, Stevioside, Camellia Sinensis Leaf Extract, Sodium Methyl Cocoyl Taurate, Ubidecarenone, Cnidium Extract, Menthol, Mint Flavor (Fragrance), Chamomilla Recutita (Matricaria) Flower Extract, Peppermint Flavor (fragrance), D.I-WATER
 O'PRECARE 12 Tocopheryl Acetate, Sorbitol, PEG-32, Cellulose Gum, Hydrated Silica, Stevioside, Xylitol, Sodium Methyl Cocoyl Taurate, Hydroxylapatite, Calcium Carbonate, Propolis Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Salvia Officinalis (SAGE) Extract, Pomegranate Extract, Spearmint Flavor (fragrance), Lemon Flavor (fragrance), Orange Oil, Menthol, Mastic Oil, D.I-WATER
 O'PRECARE 21 Silica, Tocopheryl Acetate, Piridokssin Hydrochloride, Sodium Pyrophosphate, Sorbitol, PEG-32, Hydrated Silica, Cellulose Gum, Titanium Oxide, Xylitol, Stevioside, Camellia Sinensis Leaf Extract, Sodium Methyl Cocoyl Taurate, Ubidecarenone, Cnidium Extract, Menthol, Mint Flavor (Fragrance), Chamomilla Recutita (Matricaria) Flower Extract, Peppermint Flavor (fragrance), D.I-WATER

O'PRECARE TOOTHPASTE 3SET (07,12,21)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

oprecare toothpaste 3setoprecare toothpaste 3set

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1193319sodium monofluorophosphate 0.6 % ToothpastePSN3
1193319sodium monofluorophosphate 0.006 MG/MG ToothpasteSCD3
1193319sodium monofluorophosphate 0.6 % ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71764-104-012020-01-31C16284748780-19d75b9d1-1041-f424-e053-dadaa90a57ceO'PRECARE TOOTHPASTE 3SET (07,12,21)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71764-101-01OPRECARE 3SET (07,12,21)60 g in 1 BOTTLE, PUMPGEL60 g1.71 g in 60g3
71764-101-02OPRECARE 3SET (07,12,21)1 in 1 PACKAGEGEL1.71 g in 60g3
71764-104-01OPRECARE 3SET (07,12,21)1 in 1 PACKAGEKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71764-100OPRECARE 3SET (07,12,21) (SODIUM MONOFLUOROPHOSPHATE, SILICON DIOXIDE) KIT [O'PRECARE]3Legacy NDC20171013_0d832fee-7409-46c7-bb57-475c09cfd6fc.zip
71764-101OPRECARE 3SET (07,12,21) (SODIUM MONOFLUOROPHOSPHATE, SILICON DIOXIDE) KIT [O'PRECARE]3Legacy NDC20171013_0d832fee-7409-46c7-bb57-475c09cfd6fc.zip
71764-102OPRECARE 3SET (07,12,21) (SODIUM MONOFLUOROPHOSPHATE, SILICON DIOXIDE) KIT [O'PRECARE]3Legacy NDC20171013_0d832fee-7409-46c7-bb57-475c09cfd6fc.zip
71764-104OPRECARE 3SET (07,12,21) (SODIUM MONOFLUOROPHOSPHATE, SILICON DIOXIDE) KIT [O'PRECARE]3Legacy NDC, 3 package rows20171013_0d832fee-7409-46c7-bb57-475c09cfd6fc.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71764-10471764-104-01
71764-10071764-100-01, 71764-100-02
71764-10171764-101-01, 71764-101-02
71764-10271764-102-01, 71764-102-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 53 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
SILICON DIOXIDEETJ7Z6XBU4IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
XYLITOLVCQ006KQ1EIACT
MENTHOLL7T10EIP3AIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
UBIDECARENONEEJ27X76M46IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STEVIOSIDE0YON5MXJ9PIACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHAMOMILEFGL3685T2XIACT
SILICON DIOXIDEETJ7Z6XBU4ACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SORBITOL506T60A25RIACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
HYDRATED SILICAY6O7T4G8P9IACT
STEVIOSIDE0YON5MXJ9PIACT
XylitolVCQ006KQ1EIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
Calcium CarbonateH0G9379FGKIACT
PROPOLIS WAX6Y8XYV2NOFIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CHAMOMILEFGL3685T2XIACT
SALVIA OFFICINALIS ROOT236QY0A1BLIACT
POMEGRANATE56687D1Z4DIACT
ORANGE OILAKN3KSD11BIACT
MentholL7T10EIP3AIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SORBITOL506T60A25RIACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
XylitolVCQ006KQ1EIACT

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
fca63307-fa15-4f20-b6f1-1e9ce69045670d832fee-7409-46c7-bb57-475c09cfd6fc2017-10-12WarningsExact identifier
spl id: fca63307-fa15-4f20-b6f1-1e9ce6904567
spl set id: 0d832fee-7409-46c7-bb57-475c09cfd6fc

Reported adverse events (FAERS/openFDA)#

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