DENTAL CLINIC 2080 CAVITY PROTECTION- sodium monofluorophosphate paste 
Aekyung Ind. Co., Ltd.

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.

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:67225-0001
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.156 g  in 120 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL (UNII: 506T60A25R) 69.6 g  in 120 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 2.64 g  in 120 g
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) 0.48 g  in 120 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 0.3 g  in 120 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.156 g  in 120 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.3 g  in 120 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67225-0001-1 120 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 12/01/2012
Labeler - Aekyung Ind. Co., Ltd. (687995647)
Establishment
Name Address ID/FEI Business Operations
Aekyung Ind. Co., Ltd. 687995647 manufacture(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.