Your browser does not support JavaScript! DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUNG IND. CO., LTD.]
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DENTAL CLINIC 2080 CAVITY PROTECTION (sodium monofluorophosphate) paste
[Aekyung Ind. Co., Ltd.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

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

image descriptionBox Label

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 ION0.156 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL69.6 g  in 120 g
SODIUM LAURYL SULFATE2.64 g  in 120 g
CARBOXYMETHYLCELLULOSE SODIUM0.48 g  in 120 g
TITANIUM DIOXIDE0.3 g  in 120 g
SACCHARIN SODIUM0.156 g  in 120 g
ALPHA-TOCOPHEROL ACETATE0.3 g  in 120 g
Packaging
#Item CodePackage Description
1NDC:67225-0001-1120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/01/2012
Labeler - Aekyung Ind. Co., Ltd. (687995647)
Establishment
NameAddressID/FEIBusiness Operations
Aekyung Ind. Co., Ltd.687995647manufacture(67225-0001)

Revised: 12/2012
Document Id: f07e841e-c5bc-4c49-94ca-d34be80c1c16
Set id: b9f48a5f-b2a9-4e36-ae67-539d6c0a1f80
Version: 1
Effective Time: 20121211
 
Aekyung Ind. Co., Ltd.

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