Cool Ice

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 60mg in 120g
Labeler: Sungwon Pharmaceutical Co., Ltd.
NDC Code: 76058-104

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.

Drug Facts

SODIUM MONOFLUOROPHOSPHATE (60mg)

Anticavity

Keep out of reach of children.

Keep out of reach of Children.

Direction
Adult - brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

Put the toothpaste onto the toothbrush properly before using.


Tea Catechin
Sage Extract
Lemon Extract
Methyl P Hydroxybenzoate
Sodium Lauryl Sulfate
Peppermint Oil
Lemon Menthol
Dionized WaterSilicon Dioxide
Sorbitol
Glycerine
Xylitol
Steviol Glycoside
Carbomer 940
Polyquaternium
Arginine
FD and C Blue No.1
Erythritol


COOL ICE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76058-104
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE60 mg  in 120 g
Inactive Ingredients
Ingredient NameStrength
ERYTHRITOL 
SILICON DIOXIDE 
SORBITOL 
GLYCERIN 
XYLITOL 
STEARYL GLUCOSIDE 
CARBOMER HOMOPOLYMER TYPE C 
POLYQUATERNIUM-10 (400 CPS AT 2%) 
ARGININE 
FD&C BLUE NO. 1 
SAGE  
LEMON 
METHYLPARABEN 
SODIUM LAURYL SULFATE 
PEPPERMINT OIL 
LEVOMENTHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:76058-104-021 CONTAINER (CONTAINER) in 1 CARTON
1NDC:76058-104-01120 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/05/2001
Labeler - Sungwon Pharmaceutical Co., Ltd. (689787898)
Registrant - Sungwon Pharmaceutical Co., Ltd. (689787898)

Revised: 08/2011
 
Sungwon Pharmaceutical Co., Ltd.

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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