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Dental Clinic 2080 Cavity Protection

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.208g in 160g
Labeler: Aekyung Industrial Co., Ltd.
NDC Code: 67225-0001

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.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Keep out of reach of children under 6 years of age

Sodium monofluorophosphate 0.75% (0.13% w/v Fluoride ion)

Sodium carboxymethylcellulose, Sodium lauryl sulfate, Sodium saccharin, Sorbitol, Titanium dioxide, Tocopheryl acetate, water

Purpose Anticavity

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 doctor.

Instruct children under 6 years of age in good brushing ad rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

Children under 2 years of age

Consult a dentist or doctor

Aids in the prevention of dental cavities

DENTAL CLINIC 2080 CAVITY PROTECTION 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67225-0001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION0.208 g  in 160 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL92.8 g  in 160 g
SODIUM LAURYL SULFATE3.52 g  in 160 g
CARBOXYMETHYLCELLULOSE SODIUM0.64 g  in 160 g
TITANIUM DIOXIDE0.4 g  in 160 g
SACCHARIN SODIUM0.208 g  in 160 g
ALPHA-TOCOPHEROL ACETATE0.4 g  in 160 g
Packaging
#Item CodePackage Description
1NDC:67225-0001-21 TUBE in 1 PACKAGE
1160 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/01/2015
Labeler - Aekyung Industrial Co., Ltd. (687995647)
Establishment
NameAddressID/FEIOperations
Aekyung Ind. Co., Ltd._Chungyang Factory690511126manufacture(67225-0001)

Revised: 07/2016
 
Aekyung Industrial Co., Ltd.

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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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