OPRECARE 3SET (07,12,21)- sodium monofluorophosphate, silicon dioxide kit

OPRECARE 3SET (07,12,21) by

Drug Labeling and Warnings

OPRECARE 3SET (07,12,21) 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

• O'PRECARE 07: Sodium Monofluorophosphate (0.6%)
• O'PRECARE 12: Silica (Silicon dioxide) (2.85%)
• O'PRECARE 21: Sodium Monofluorophosphate (0.6%)

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

• O'PRECARE 07: 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 12: 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 21: 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 TOOTHPASTE 3SET (07,12,21)

INGREDIENTS AND APPEARANCE

OPRECARE 3SET (07,12,21) 
sodium monofluorophosphate, silicon dioxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71764-104

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71764-104-01	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package	10/12/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PUMP	60 g
Part 2	1 BOTTLE, PUMP	60 g
Part 3	1 BOTTLE, PUMP	60 g

Part 1 of 3

OPRECARE 07 
sodium monofluorophosphate paste

Product Information
Item Code (Source)	NDC: 71764-100
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.36 g  in 60 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71764-100-02	1 in 1 PACKAGE
1	NDC: 71764-100-01	60 g in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/12/2017

Part 2 of 3

OPRECARE 12 
silicon dioxide gel

Product Information
Item Code (Source)	NDC: 71764-101
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	1.71 g  in 60 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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71764-101-02	1 in 1 PACKAGE
1	NDC: 71764-101-01	60 g in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package

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

Part 3 of 3

OPRECARE 21 
sodium monofluorophosphate gel

Product Information
Item Code (Source)	NDC: 71764-102
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.36 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
Xylitol (UNII: VCQ006KQ1E)
Stevioside (UNII: 0YON5MXJ9P)
Hydrated Silica (UNII: Y6O7T4G8P9)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
Menthol (UNII: L7T10EIP3A)
LICORICE (UNII: 61ZBX54883)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
Allantoin (UNII: 344S277G0Z)
PIRIDOCAINE HYDROCHLORIDE (UNII: VG6P406YHV)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
Lemon Oil (UNII: I9GRO824LL)
Orange Oil (UNII: AKN3KSD11B)
Eucalyptus Oil (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71764-102-02	1 in 1 PACKAGE
1	NDC: 71764-102-01	60 g in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/12/2017

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(71764-104)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(71764-104)