PLAK SMACKER MINT BLAST- sodium fluoride paste 
LMZ

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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Mint Blast Toothpaste

Active Ingredients

Sodium Fluoride 0.243% (equivalent to 0.13% w/v fluoride ion)

Purpose

Anti-cavity

Uses

Aids in the prevention of cavities

Warnings

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

Keep out of reach of children under 6 years of age.

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

Sorbitol, Silica, Water, PEG-8, Sodium lauryl sulfate, Flavor, Titanium dioxide, Cellulose gum, Trisodium phosphate, Sodium saccharin, Xanthan gum, Benzyl alcohol, Xylitol, CI 42090

Principal Display Panel

28 g NDC: 71775-080-01

Mint Blast 28 g

PLAK SMACKER  MINT BLAST
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71775-080
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION130 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71775-080-0128 g in 1 TUBE; Type 0: Not a Combination Product03/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/18/2021
Labeler - LMZ (654623156)
Establishment
NameAddressID/FEIBusiness Operations
LMZ654623156manufacture(71775-080)

Revised: 3/2021
Document Id: bdd574e2-7d95-64b9-e053-2995a90a0386
Set id: bdd574e2-7d94-64b9-e053-2995a90a0386
Version: 1
Effective Time: 20210318
 
LMZ