Label: DENTAL CLINIC 2080 CAVITY PROTECTION- sodium monofluorophosphate paste
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Contains inactivated NDC Code(s)
NDC Code(s): 67225-0001-1 - Packager: Aekyung Ind. Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated December 11, 2012
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WARNINGS
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DENTAL CLINIC 2080 CAVITY PROTECTION
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67225-0001 Route of Administration DENTAL 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)
