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OPRECARE 07

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.36g in 60g
Labeler: O'PRECARE
NDC Code: 71764-100

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

O'PRECARE 07

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

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 07

OPRECARE 07 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71764-100
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION0.36 g  in 60 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
XYLITOL 
MENTHOL 
SODIUM METHYL COCOYL TAURATE 
GREEN TEA LEAF 
UBIDECARENONE 
SODIUM PYROPHOSPHATE 
SORBITOL 
HYDRATED SILICA 
TITANIUM DIOXIDE 
STEVIOSIDE 
POLYETHYLENE GLYCOL 1500 
.ALPHA.-TOCOPHEROL ACETATE 
CHAMOMILE 
Packaging
#Item CodePackage Description
1NDC:71764-100-021 BOTTLE, PUMP in 1 PACKAGE
1NDC:71764-100-0160 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/12/2017
Labeler - O'PRECARE (694604592)
Registrant - O'PRECARE (694604592)
Establishment
NameAddressID/FEIOperations
O'PRECARE694604592relabel(71764-100)
Establishment
NameAddressID/FEIOperations
Kolmar Korea Co., Ltd.689512611manufacture(71764-100)

Revised: 10/2017
 
O'PRECARE

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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