OPRECARE 07

Manufacturer: O'PRECARE | Kolmar Korea Co., Ltd.
Effective date: 2017-10-11
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:52:41

Label at a glance#

ProductOPRECARE 07

Active ingredientSODIUM MONOFLUOROPHOSPHATE

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

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

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 07

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

oprecare 07 draft

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1193319	sodium monofluorophosphate 0.6 % Toothpaste	PSN	3
1193319	sodium monofluorophosphate 0.006 MG/MG Toothpaste	SCD	3
1193319	sodium monofluorophosphate 0.6 % Toothpaste	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71764-100-02	2020-01-31	C162847	48780-1	9d75b9d0-e440-f424-e053-dadaa90a57ce	O'PRECARE 07

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71764-100-01	OPRECARE 07	60 g in 1 BOTTLE, PUMP	PASTE	60		3
71764-100-02	OPRECARE 07	1 in 1 PACKAGE	PASTE	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71764-100	OPRECARE 07 (SODIUM MONOFLUOROPHOSPHATE) PASTE [O'PRECARE]	3	Legacy NDC, 2 package rows	20171013_5a1cf9b3-6a74-0805-e053-2991aa0ab837.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

OPRECARE 07
Sodium Monofluorophosphate
FLUORIDE ION
SILICON DIOXIDE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
XYLITOL
MENTHOL
SODIUM METHYL COCOYL TAURATE
GREEN TEA LEAF
UBIDECARENONE
SODIUM PYROPHOSPHATE
SORBITOL
HYDRATED SILICA
TITANIUM DIOXIDE
STEVIOSIDE
POLYETHYLENE GLYCOL 1500
.ALPHA.-TOCOPHEROL ACETATE
CHAMOMILE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71764-100	71764-100-01, 71764-100-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIM
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	K679OBS311	IACT
XYLITOL	VCQ006KQ1E	IACT
MENTHOL	L7T10EIP3A	IACT
SODIUM METHYL COCOYL TAURATE	JVL98CG53G	IACT
GREEN TEA LEAF	W2ZU1RY8B0	IACT
UBIDECARENONE	EJ27X76M46	IACT
SODIUM PYROPHOSPHATE	O352864B8Z	IACT
SORBITOL	506T60A25R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
STEVIOSIDE	0YON5MXJ9P	IACT
POLYETHYLENE GLYCOL 1500	1212Z7S33A	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
CHAMOMILE	FGL3685T2X	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
1eb7bd27-ef41-493c-8fd0-875e72f830cd			5a1cf9b3-6a74-0805-e053-2991aa0ab837	2017-10-11	Warnings	Exact identifier spl id: 1eb7bd27-ef41-493c-8fd0-875e72f830cd spl set id: 5a1cf9b3-6a74-0805-e053-2991aa0ab837

Reported adverse events (FAERS/openFDA)#

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