OPRECARE 24- silicon dioxide gel

OPRECARE 24 by

Drug Labeling and Warnings

OPRECARE 24 by is a Otc medication manufactured, distributed, or labeled by O'PRECARE, Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

OPRECARE 24 
silicon dioxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71764-103
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	1.425 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
.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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71764-103-02	1 in 1 PACKAGE	10/12/2017
1	NDC: 71764-103-01	50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/12/2017

Labeler - O'PRECARE (694604592)

Registrant - O'PRECARE (694604592)

Establishment
Name	Address	ID/FEI	Business Operations
O'PRECARE		694604592	relabel(71764-103)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(71764-103)