OPRECARE 24- 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 24

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

Silica, Tocopheryl Acetate, Sorbitol, PEG-32, Xylitol, Stevioside, Hydrated Silica, Cellulose Gum, Sodium Methyl Cocoyl Taurate, Menthol, Liquorice, Propolis Extract, Allantoin, Piridokssin Hydrochloride, Camellia Sinensis Leaf Extract, Citron Flavor (fragrance), Lemon Oil, Orange Oil, Eucalyptus Oil, D.I-WATER

O'PRECARE 24

oprecare 24

OPRECARE 24 
silicon dioxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71764-103
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE1.425 g  in 50 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)  
Calcium Carbonate (UNII: H0G9379FGK)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMOMILE (UNII: FGL3685T2X)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
POMEGRANATE (UNII: 56687D1Z4D)  
Ubidecarenone (UNII: EJ27X76M46)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
ORANGE OIL (UNII: AKN3KSD11B)  
Menthol (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71764-103-021 in 1 PACKAGE10/12/2017
1NDC:71764-103-0150 g in 1 TUBE; 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(71764-103)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(71764-103)

Revised: 10/2017
Document Id: 50089863-2c5c-458d-9cad-4426eccf967f
Set id: 3e37baaa-05fc-44ce-9d4a-882790069721
Version: 3
Effective Time: 20171012
 
O'PRECARE