OPRECARE 12- silicon dioxide gel 
O'PRECARE

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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O'PRECARE 12

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

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

oprecare 12 draft

OPRECARE 12 
silicon dioxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71764-101
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE1.71 g  in 60 g
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
STEVIOSIDE (UNII: 0YON5MXJ9P)  
Xylitol (UNII: VCQ006KQ1E)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Calcium Carbonate (UNII: H0G9379FGK)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMOMILE (UNII: FGL3685T2X)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
POMEGRANATE (UNII: 56687D1Z4D)  
ORANGE OIL (UNII: AKN3KSD11B)  
Menthol (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71764-101-021 in 1 PACKAGE10/12/2017
1NDC:71764-101-0160 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/12/2017
Labeler - O'PRECARE (694604592)
Registrant - O'PRECARE (694604592)
Establishment
NameAddressID/FEIBusiness Operations
O'PRECARE694604592relabel(71764-101)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(71764-101)

Revised: 10/2017
Document Id: ff17f570-3a11-4bea-8566-fab4352f95d2
Set id: 4a0329cf-3244-49b7-93cc-6b389f975d59
Version: 3
Effective Time: 20171011
 
O'PRECARE