Label: PLAK SMACKER MINT BLAST- sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 71775-080-01 - Packager: LMZ
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 March 18, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
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 a physician.
Children 2 to 6 years: To minimize swallowing use a pea sized amount. Supervise children's brushing until good habits are established.
Children under 2 years: Ask a dentist or a physician.
- Inactive Ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
PLAK SMACKER MINT BLAST
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71775-080 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 130 mg in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) BENZYL ALCOHOL (UNII: LKG8494WBH) XYLITOL (UNII: VCQ006KQ1E) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XANTHAN GUM (UNII: TTV12P4NEE) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71775-080-01 28 g in 1 TUBE; Type 0: Not a Combination Product 03/18/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 03/18/2021 Labeler - LMZ (654623156) Establishment Name Address ID/FEI Business Operations LMZ 654623156 manufacture(71775-080)