Active ingredient

Active ingredients
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

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

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)

oprecare toothpaste 3set

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

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

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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	1.71 g in 60 g

Ingredient Name	Strength
Inactive Ingredients
.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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	10/12/2017

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

Labeler - O'PRECARE (694604592)

Registrant - O'PRECARE (694604592)

Name	Address	ID/FEI	Business Operations
Establishment
O'PRECARE		694604592	relabel(71764-104)

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