OPRECARE 21- sodium monofluorophosphate gel

OPRECARE 21 by

Drug Labeling and Warnings

OPRECARE 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

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

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 21

INGREDIENTS AND APPEARANCE

OPRECARE 21 
sodium monofluorophosphate gel

Product Information
Product Type	HUMAN OTC DRUG	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	10/12/2017
1	NDC: 71764-102-01	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

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

Labeler - O'PRECARE (694604592)

Registrant - O'PRECARE (694604592)

Establishment
Name	Address	ID/FEI	Business Operations
O'PRECARE		694604592	relabel(71764-102)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(71764-102)