Indications and uses
Helps protect against cavities, plaque, gingivitis
OPRECARE 12
- 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 12
Active ingredientSILICON DIOXIDE
Label structure8 sections
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
Silica (Silicon dioxide) (2.85%)
Purpose
Anticavity
Warnings
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
Helps protect against cavities, plaque, gingivitis
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
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
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 12
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71764-101-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-60a0-f424-e053-dadaa90a57ce | O'PRECARE 12 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71764-101-01 | OPRECARE 12 | 60 g in 1 BOTTLE, PUMP | GEL | 60 | 3 | |
| 71764-101-02 | OPRECARE 12 | 1 in 1 PACKAGE | GEL | 1 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- OPRECARE 12
- Silicon Dioxide
- .ALPHA.-TOCOPHEROL ACETATE
- SORBITOL
- POLYETHYLENE GLYCOL 1500
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- HYDRATED SILICA
- STEVIOSIDE
- Xylitol
- SODIUM METHYL COCOYL TAURATE
- TRIBASIC CALCIUM PHOSPHATE
- Calcium Carbonate
- PROPOLIS WAX
- GREEN TEA LEAF
- CHAMOMILE
- SALVIA OFFICINALIS ROOT
- POMEGRANATE
- ORANGE OIL
- Menthol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71764-101 | 71764-101-01, 71764-101-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ff17f570-3a11-4bea-8566-fab4352f95d2 | 4a0329cf-3244-49b7-93cc-6b389f975d59 | 2017-10-11 | Warnings | ff17f570-3a11-4bea-8566-fab4352f95d2 4a0329cf-3244-49b7-93cc-6b389f975d59 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.